Unofficial translation
Footnote. Expired by Order of the Minister of Health of the Republic of Kazakhstan dated 20.12.2020 No. KR MHC -286/2020 (effective after ten calendar days after the date of its first official publication).In accordance with Article 68 of the Code of the Republic of Kazakhstan dated September 18, 2009 "On Public Health and Health Care System", I ORDER:
1. To approve the attached Rules for manufacturing medicines and medical products.
2. The Committee of pharmacy of the Ministry of Healthcare of the Republic of Kazakhstan in the manner established by the legislation of the Republic of Kazakhstan shall ensure:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) within ten calendar days from the date of state registration of this order, sending its copy in paper and electronic form in the Kazakh and Russian languages to the Republican state enterprise on the right of economic management "Institute of legislation and legal information of the Republic of Kazakhstan" of the Ministry of Justice of the Republic of Kazakhstan for official publication and inclusion to the Standard control bank of regulatory legal acts of the Republic of Kazakhstan;
3) placement of this order on the Internet resource of the Ministry of Healthcare of the Republic of Kazakhstan after its official publication;
4) within ten working days after the state registration of this order, submission of information on implementation of measures provided for in subparagraphs 1), 2) and 3) of this paragraph to the Department of legal service of the Ministry of Healthcare of the Republic of Kazakhstan.
3. Control over execution of this order shall be assigned to the supervising Vice-Minister of Healthcare of the Republic of Kazakhstan.
4. This order shall be enforced upon expiry of ten calendar days after its first official publication.
| Approved by the order of the Minister of Healthcare of the Republic of Kazakhstan dated April 22, 2019 № KR MHC-45 |
Rules for manufacturing medicines and medical products
Chapter 1. General provisions
1. These Rules for manufacturing medicines and medical products (hereinafter – the Rules) shall determine the procedure for manufacturing medicines and medical products.
2. Manufacturing medicines and medical products shall be carried out by entities in the sphere of circulation of medicines and medical products, having the appropriate license to manufacture medicines and medical products.
3. The following terms are used in these Rules:
1) manufacturing medicines – pharmaceutical activity, related to the manufacture of medicines in pharmacies, with the acquisition of pharmaceutical substances (active pharmaceutical substances) for pharmaceutical use, storage, quality control, registration and sale of manufactured medicines;
2) manufacturing medical products – pharmaceutical activity, related to manufacturing medical products in pharmacies, medical products stores and optics stores;
3) good manufacturing practice – a national standard in the field of circulation of medicines and medical products, establishing requirements for organization of manufacture, manufacturing process and control in the manufacture of medicines and medical products;
4) sterile medical products – medical products in a certain medicinal form that have passed the process of sterilization in the absence of living organisms.
4. Manufacturing medicines and medical products shall be carried out on the basis of medicines registered in the Republic of Kazakhstan, with the exception of medicinal substances produced in good manufacturing practice.
5. The technology of manufacturing medicines and medical products, produced in a pharmacy, medical products store and optics store shall be carried out in accordance with the requirements of general Articles of the State Pharmacopoeia of the Republic of Kazakhstan, individual pharmacopoeia articles, foreign pharmacopoeia recognized as valid on the territory of the Republic of Kazakhstan, regulatory documents, approved by the authorized body in the field of healthcare.
6. Medical organizations that do not have a pharmacy with the right to manufacture medicines shall not be allowed to manufacture and (or) package medicines, to transfer medicines from one package to another, or to replace labels.
Chapter 2. The procedure for manufacturing medicines
7. Medicines are manufactured taking into account the following conditions:
1) compliance with the rules for writing prescriptions in accordance with the Rules for writing, accounting and storage of prescriptions, approved by the order of Minister of Healthcare and Social Development of the Republic of Kazakhstan dated May 22, 2015 № 373 (registered in the Register of state registration of regulatory legal acts under № 11465), compliance with prescribed doses to a patient's age, norms of lump-sum delivery, compatibility of ingredients included in the composition of the medical product;
2) compliance with manufacturing technology of medicines;
3) providing the medicine with appropriate labeling and packaging;
4) ensuring the proper delivery of the medicine and providing the patient with objective information about the medicine with understandable terms for their use and storage.
8. Manufacturing medicines shall be carried out:
1) according to doctors ' prescriptions;
2) according to the requirements of medical organizations;
3) in the form of an intra-pharmacy preparation.
9. In manufacturing medicines, deviations are allowed, within the limits of the norms allowed in manufacturing medicines (including homeopathic) in the pharmacy, the permissible error in measuring the value of acid-base balance according to Appendices 1, 2 to these Rules.
10. The conditions for sterilization, storage and shelf life of medicines manufactured in a pharmacy are set according to Appendix 3 to these Rules.
11. Medicines from the pharmacy shall be delivered only to authorized medical personnel under a power of attorney issued in the manner established by the legislation of the Republic of Kazakhstan to medical organizations.
12. In aseptic conditions, sterile medicines shall be manufactured, such as:
1) medicines for newborns;
2) solutions for injections and infusions;
3) irrigation solutions introduced into cavities that do not contain microorganisms;
4) liquid medicines for newborns and children under one year of age;
5) medicines in the form of a liquid dosage form containing antibiotics and other antimicrobial substances, as well as intended for application to wounds and burn surfaces;
6) eye drops, ophthalmic solutions for irrigation and lotions;
7) concentrated solutions (including homeopathic dilutions);
8) liquid medicines in the form of intra- pharmacy preparation.
13. It is not allowed to manufacture sterile medical products in the absence of data on chemical compatibility of medicinal substances included in them, technology and mode of sterilization.
14. It is not allowed to simultaneously produce several sterile solutions containing medicinal substances with different names or the same name, but in different concentrations, at the same workplace.
15. Results of control of separate stages of production of solutions for injections and infusions shall be registered in the registration journal of control results of separate stages of production of solutions for injections and infusions in the attached form according to Appendix 4 to these Rules. The journal is numbered, laced, signed by the head of the pharmacy and sealed with the pharmacy's seal.
16. Control of sterile solutions for the absence of mechanical inclusions shall be carried out before and after sterilization.
Pharmacies check the volume of solutions in vials (bottles) and the quality of their capping.
It is not allowed to scroll the metal cap "under running-in" when checking manually and pouring out the solution when tipping the vial (bottle)).
17. Vials with solutions after capping shall be marked by writing, stamping on the lid or using metal tokens indicating the name and concentration.
18. Sterilization of solutions shall be conducted no later than three hours from the start of production, under the supervision of a specialist (pharmacist or pharmaceutist).
Repeated sterilization of solutions is not allowed.
Registration of sterilization parameters shall be made in the registration journal of sterilization mode of initial medicinal substances, manufactured medical products, auxiliary materials, utensils in the form according to Appendix 5 to these Rules. The journal is numbered, laced, signed by the head of the pharmacy and sealed with the pharmacy's seal.
19. The nomenclature of concentrates, semi-finished products and intra-store preparations of medicines manufactured in the pharmacy shall be approved annually by an accredited testing laboratory, with which an agreement on control and analytical services has been concluded. This list includes medicines containing compatible active and auxiliary substances, for which there are methods of analysis for complete chemical control with established expiration dates.
Chapter 3. Procedure for manufacturing medical products
20. Medical products shall be manufactured taking into account the following conditions:
1) when using them for their intended purpose (during operation), in accordance with the instructions and information provided by the manufacturer of the products, safety shall be ensured and the health of patients and users shall not be at risk;
2) their characteristics shall be preserved during storage and transportation;
3) risk of infection of patients, users, and contamination of the products themselves shall be eliminated or minimized.
21. Technical characteristics and functional properties of medical products are not deteriorated during the service life of the medical product, specified by the manufacturer, under the influence of external factors, and do not threaten the health and safety of patients, users during normal operation of the products in conditions, complying with the manufacturer's operating instructions.
22. Medical products intended for administration of drugs have compatibility with these medicines, taking into account the functional properties of medical products according to the purpose, conditions of use and storage of these drugs.
23. Manufacturing medical optics shall be performed on machines specially designed for processing optical lenses in accordance with a prescription issued to a specific patient.
24. It is mandatory to check the accuracy of manufactured glasses on special equipment (diopter) in the presence of the client, for compliance with the prescription data.
Appendix 1
to the Rules for manufacturing
medicines and
medical products
Norms of deviations allowed in manufacturing medicines (including homeopathic) in the pharmacy
1. Deviations allowed in the mass of individual doses when packaging powders, including powder dispensers, are determined by the prescribed dose of one powder.
Deviations allowed in the total mass of homeopathic triturations are determined by the prescribed mass of triturations.
Prescribed mass, g | Deviations % |
1 | 2 |
Up to 0.1 | ±15 |
More than 0.1 to 0.3 | ±10 |
More than 0,3 to 1 | ±5 |
More than 1 to 10 | ±3 |
More than 10 to 100 | ±3 |
More than 100 to 250 | ±2 |
More than 250 | ±0,3 |
2. Deviations allowed in the total mass of homeopathic granules (including packaging) for one package:
Prescribed mass, g | Deviations % |
1 | 2 |
Up to 1 | ±5 |
More than 1 to 100 | ±3 |
3. Deviations allowed in the mass of individual doses of suppositories and pills:
1) determine the average mass by weighing (up to 0.01 g) at least 10 suppositories or pills. When producing less than 10 pieces, all suppositories are weighed;
2) deviations in the mass of suppositories and pills from the average mass are determined by weighing each suppository or pill with a minimum sample of 5 pieces;
3) it is not allowed to exceed the permissible deviations from the average mass:
for suppositories ± 5 %;
for pills weighing up to 0.3 g ± 10 %;
for pills weighing more than 0.3 g ± 5 %.
4. Deviations allowed in the mass of prescribed doses of individual drugs in powders, pills and suppositories (when manufactured by rolling or pouring) are determined by the dose of each substance included in these medicines:
Prescribed mass, g | Deviations % |
1 | 2 |
Up to 0,02 | ±20 |
More than 0,02 to 0,05 | ±15 |
More than 0,05 to 0,2 | ±10 |
More than 0,2 to 0,3 | ±8 |
More than 0,3 to 0,5 | ±6 |
More than 0,5 to 1 | ±5 |
More than 1 to 2 | ±4 |
More than 2 to 5 | ±3 |
More than 5 to 10 | ±2 |
More than 10 | ±1 |
5. Deviations allowed in the total volume of liquid medicines in manufacturing by mass-volume method, as well as in subparagraphs 7, 9, it should be borne in mind that deviations are provided for liquid medicines in the manufacture with the use of both concentrates and dry substances:
Prescribed volume, ml | Deviations % |
1 | 2 |
Up to 10 | ±10 |
More than 10 to 20 | ±8 |
More than 20 to 50 | ±4 |
More than 50 to 150 | ±3 |
More than 150 to 200 | ±2 |
More than 200 | ±1 |
6. Deviations, allowed when packing solutions for injection, manufactured in the form of an intra-pharmacy preparation:
Prescribed volume, ml | Deviations % |
1 | 2 |
Up to 50 | ±10 |
More than 50 | ±5 |
When measuring (and packing) liquids after draining with a jet, an excerpt for draining drops is given: for non-viscous liquids – for one minute, for viscous liquids - for three minutes.
7. Deviations allowed when determining the content of individual medicinal substances in liquid medicines in the manufacture by mass-volume method:
Prescribed mass, g | Deviations % |
1 | 2 |
Up to 0,02 | ±20 |
More than 0,02 to 0,1 | ±15 |
More than 0,1 to 0,2 | ±10 |
More than 0,2 to 0,5 | ±8 |
More than 0,5 to 0,8 | ±7 |
More than 0,8 to 1 | ±6 |
More than 1 to 2 | ±5 |
More than 2 to 5 | ±4 |
More than 5 | ±3 |
8. Deviations allowed in the mass of liquid medicines in the manufacture by the mass method:
Prescribed mass, g | Deviations % |
1 | 2 |
Up to 10 | ±10 |
More than 10 to 20 | ±8 |
More than 20 to 50 | ±5 |
More than 50 to 150 | ±3 |
More than 150 to 200 | ±2 |
More than 200 | ±1 |
9. Deviations allowed in the mass of incoming individual medicinal substances in liquid medicines when manufactured by the mass method, and in ointments:
Prescribed mass, g | Deviations % |
1 | 2 |
Up to 0,1 | ±20 |
More than 0,1 to 0,2 | ±15 |
More than 0,2 to 0,3 | ±12 |
More than 0,3 to 0,5 | ±10 |
More than 0,5 to 0,8 | ±8 |
More than 0,8 to 1 | ±7 |
More than 1 to 2 | ±6 |
More than 2 to 10 | ±5 |
More than 10 | ±3 |
Deviations allowed in determining the content of incoming individual medicinal substances in liquid medicines when manufactured by mass or mass-volume method, as well as in ointments, are determined not by the concentration as a percentage, but by the prescribed mass of the incoming substance in these medicines according to subparagraphs 7, 9 of this Appendix.
In manufacturing 10 ml of 2% solution of pilocarpine hydrochloride, a mass of 0.2 g shall be taken, for which a deviation of +-10 % is allowed. In the analysis, it is sufficient to establish that no less than 0.18 g and no more than 0.22 g of pilocarpine hydrochloride were taken.
10. Deviations allowed in the total mass of ointments:
Prescribed mass, g | Deviations % |
1 | 2 |
Up to 5 | ±15 |
More than 5 to 10 | ±10 |
More than 10 to 20 | ±8 |
More than 20 to 30 | ±7 |
More than 30 to 50 | ±5 |
More than 50 to 100 | ±3 |
More than 100 | ±2 |
11. Deviations allowed in concentrates when containing the medicinal substance:
up to 20 % not more than ± 2 % of the specified percentage;
More than 20 % no more than ± 1 % of the specified percentage.
This paragraph specifies the deviations from the concentration (in percentages), allowed in concentrates when they are manufactured both by mass-volume method and by mass method.
12. Deviations, allowed in homeopathic triturations, solutions and dilutions of liquid medicines:
1) when the content of medicinal substance is 10 % (the first decimal dilution is D1), no more than ± 5 % of the specified percentage;
2) when the content of medicinal substance is 1 % (second decimal dilution-D2), no more than ±5 % of the specified percentage;
D3) when the content of medicinal substance is 0.1 % (third decimal dilution-D3) no more than ±10 % of the specified percentage.
This paragraph specifies the deviations from the concentration (in percentages), allowed in homeopathic triturations, solutions and dilutions of liquid medicines when they are manufactured as concentrates and semi-finished products.
When determining the permissible deviations in the tested medicines, manufactured in the form of a series of intra-pharmacy preparations, the norms of deviations given in subparagraphs 1-10 of this Appendix, as well as in the current regulatory documentation regulating the manufacture and quality control of various medicines in the pharmacy should be used.
In manufacturing medicines in the form of series of intra-pharmacy preparations, the deviations, allowed in the mass of incoming individual substances are determined by the mass of each incoming substance taken for the manufacture of the required volume (or mass) of this series (in one container from one load of the medicine).
In manufacturing 2 liters of 0.9 % sodium chloride solution, the mass of the incoming substance 18 g is taken, for which a deviation of ± 3% is allowed. During chemical control, it is sufficient to establish that no less than 17.46 g and no more than 18.54 g of sodium chloride were taken.
Deviations, allowed in the mass of incoming individual substances in medicines, manufactured in the form of series of intra-pharmacy preparations and withdrawn from the pharmacy for testing are determined as indicated above in paragraph 2 and paragraph 3.
When considering a medicine withdrawn for testing according to the prescription "0.9 % - 200 ml sodium chloride solution" during chemical control, it is sufficient to establish that the solution contains at least 1.71 g and not more than 1.89 g of sodium chloride (deviation of ± 5% according to paragraph 7 of this Appendix).
13. When checking medicines manufactured in a homeopathic pharmacy for individual prescriptions, the norms of deviations given in paragraphs 1-4, 8-10 of this Appendix should be used.
| Appendix 2 to the Rules for manufacturing medicines and medical products |
Norm of permissible error when measuring the value of acid-base balance
Measurement method | Maximum error in units of acid-base balance when measuring (acid-base balance measurements are performed in comparison with purified water or water for injection) | |
with an interval рН 1-2 | with an interval рН 0,3-0,7 | |
1 | 2 | 3 |
Potentiometric | 0,6 | 0,05 |
By indicator paper | 1 | 0,3 |
| Appendix 3 to the Rules for manufacturing medicines and medical products |
Conditions for sterilization, storage and shelf life of medicines manufactured in a pharmacy
1. Sterile solutions in vials and bottles, hermetically sealed with rubber stoppers for running-in
№ п/п | Name | Composition | Expiration date in days at t0 not higher than 2500C | Storage conditions | Mode of sterilization (temperature, time) |
1 | 2 | 3 | 4 | 5 | 6 |
1. Solutions for injections and infusions | |||||
1 |
Solution of analgin 25 %; 50 % |
Analgin 250 g; 500 g | 30 | In a dark place | 1200C-8 min. |
2 |
Solution of apomorphine hydrochloride 1 % |
Apomorphine hydrochloride 10 g | 30 | In a dark place, in a lockable cabinet | 1200С – 8 min. |
3 | Solution of atropine sulfate 0,05 %; 0,1 %; 1 %; 2,5 %; 5 % |
Atropine sulfate 0.5 g; 1 g; 10 g; 25 g; 50 g | 30 | In a dark place, in a lockable cabinet | 1200С – 8 min. |
4 |
Solution "Atsesol" |
Sodium acetate 2 g | 30 | 1200С – 8 min. | |
5 | Water for injection | 30 | 1200С – 8 min. | ||
6 | Solution of glycerol 10 % |
Glycerol (in terms of anhydrous) 100 g | 30 | 1200С – 8 min. | |
7 |
Solution of glucose 5 %; 10 %; 20 %; 25 % |
Glycerol (in terms of anhydrous) 50 g; 100 g; 200 g; 250 g | 30 | 1200С – 8 min. | |
8 |
Solution of glucose 5 % with potassium chloride 0.5 % or 1 % |
Glucose (in terms of anhydrous) 50 g | 60 | 1200С – 8 min. | |
9 | Solution of glucose 10% saline |
Glucose (in terms of anhydrous) 10 g | 90 | 1200С – 8 min. | |
10 |
Solution of glucose citrate |
Glucose (in terms of anhydrous) 22.05 g | 30 | 1200С – 8 min. | |
11 |
Solution of dibazol 0,5 %; 1 %; 2 % |
Dibazole 5 g; 10 g; 20 g |
60-for 0,5 % and | 1200С – 8 min. | |
12 | Solution of dikain 0.1 %; 0.25 %; 0.3 % |
Dikain 1 g; 2.5 g; 3 g | 30 | In a lockable cabinet | 1200С – 8 min. |
13 |
Solution of dikain 1 %; 2 % |
Dikain 10 g; 20 g | 90 | In a lockable cabinet | 1200С – 8 min. |
14 |
Solution of diphenhydramine 1 %; 2 % |
Diphenhydramine 10 g; 20 g | 30 | In a dark place | 1200С – 8 min. |
15 |
Solution "Disol" |
Sodium chloride 6 g | 30 | 1200С – 8 min. | |
16 | Petrov's blood-replacing liquid |
Sodium chloride 15 g | 30 | 1200С – 8 min. | |
17 |
Solution of potassium chloride 0,5 %; 1 %; 3 %; 5 %; 7,5 %; 10 % |
Potassium chloride 5 g; | 30 | 1200С – 8 min. | |
18 |
Solution of potassium chloride 0.25 %; |
Potassium chloride 2.5 g; 5 g; 10 g | 30 | 1200С – 8 min. | |
19 |
Solution of calcium gluconate 10 % |
Calcium gluconate 100 g | 7 | 1200С – 8 min. | |
20 |
Solution of calcium 0,25 %; 0,5 %; 1 %; 5 %; 10 % |
Calcium chloride 2.5 g; 5 g; 10 g; 50 g; 100 g | 30 | 1200С – 8 min. | |
21 |
Cardioplegic solution № 1 |
Sodium chloride 4.5 g | 6 months | 1200С – 8 min. | |
22 |
Cardioplegic solution № 3 |
Sodium chloride 4.5 g | 12 months | 1200С – 8 min. | |
23 |
Solution "Kvartasol" |
Sodium bicarbonate 1 g | 90 | 1200С – 8 min. | |
24 | Solution of aminocaproic acid 5 % |
Aminocaproic acid 50 g | 30 | In a dark place | 1200С – 8 min. |
25 | Solution of ascorbic acid 5 %; 10 % |
Ascorbic acid 50 g; 100 g | 30 | In a dark place | 1200С – 8 min. |
26 |
Solution of glutamic acid 1 % |
Glutamic acid 10 g | 30 | In a dark place | |
27 |
кислоты никотиновой 1 % |
Nicotinic acid 10 g | 60 | In a dark place | 1200С – 8 min. |
28 | Solution of caffeine-benzoate 10 %; 20 % |
Caffeine-sodium benzoate 100 g; 200 g | 30 | 1200С – 8 min. | |
29 | Solution of magnesium sulfate 10 %; 20 %; 25 %; 33 % |
Magnesium sulfate 100 g; 200 g; 250 g; 330 g | 30 | 1200С – 8 min. | |
30 |
Methylene blue solution 0.02 %; 1 % |
Methylene blue 0.2 g; 10 g | 30 | 1200С – 8 min. | |
31 | Solution of sodium benzoate 15 % |
Sodium benzoate 150 g | 30 | ||
32 |
Solution of sodium bromide 5 %; 10 %; 20 % |
Sodium bromide 50 g; 100 g; 200 g | 30 | In a dark place | 1200С – 8 min. |
33 |
Solution of sodium bicarbonate 3 %;4 %; 5 %; 7 % |
Sodium bicarbonate 30 g; 40 g; 50 g; 70 g | 30 | 1200С – 8 min. | |
34 | Solution of sodium bicarbonate 3 %; 4 %; 5 %; 7 %; 8,4 % stabilized |
Sodium bicarbonate 30 g; 40 g; 50 g; 70 g; 84 g | 30 | 1200С – 8 min. | |
35 |
Solution of sodium hydrocitrate 4 %; 5 %; 6 % |
Sodium hydrocitrate 40 g; 50 g; 60 g | 30 | 1200С – 8 min. | |
36 |
Solution of sodium iodide 5 %; 10 %; 20 % |
Sodium iodide 50 g; 100 g; 200 g | 30 | In a dark place | 1200С – 8 min. |
37 | Solution of sodium paraaminosalicylate 3 % |
Sodium paraaminosalicylate 30 g | 7 | In a dark place | 1200С – 8 min. |
38 |
Solution of sodium salicylate 3 %; 10 % |
Sodium salicylate 30 g; 100 g | 30 | In a dark place | 1200С – 8 min. |
39 |
Solution of sodium chloride 0,45 %; 0,9 %; |
Sodium chloride 4.5 g; 9 g; 58.5 g; 100 g | 90 | 1200С – 8 min. | |
40 | Solution of sodium citrate 4 %; 5 % |
Sodium citrate (in terms of dry matter) 40 g; 50 g | 30 | 1200С – 8 min. | |
41 | Solution of nicotinamide 1 %; 2 %; 2,5 %; 5 % |
Nicotinamide 10 g; 20 g; 25 g; 50 g | 30 | In a dark place | 1200С – 8 min. |
42 |
Solution of novocaine 0,25 %; 0,5 %; 1 %; 2 % |
Novocaine 2.5 g; 5 g; 10 g; 20 g | 30 | In a dark place | 1200С – 8 min. |
43 | Solution of novocaine 2 %; 5 %; 10 % |
Novocaine 20 g; 50 g; 100 g | 90 | In a dark place | 1200С – 8 min. |
44 |
Solution of norsulfazol-sodium 5 %; 10 % |
Norsulfazol-sodium (in terms of dry matter) 50 g; 100 g |
5 % - 30 | In a dark place | 1200С – 8 min. |
45 |
Solution of papaverine hydrochloride 2 % |
Papaverine hydrochloride 20 g | 30 | In a dark place | 1200С – 8 min. |
46 |
Ringer's Solution |
Sodium chloride 9 g | 30 | 1200С – 8 min. | |
47 | Ringer-acetate solution |
Sodium chloride 5.26 g | 30 | 1200С – 8 min. | |
48 | Ringer-Locke solution (the medicine is prepared by mixing equal volumes of two separately prepared and sterilized solutions, one of which is a solution of sodium bicarbonate, the other-glucose with salts) |
Sodium chloride 9 g | The expiration date of each solution is 30 days | 1200С – 8 min. | |
49 |
Evans blue solution 0.5 % |
Evans blue (in terms of anhydrous) 5 g | 30 | 1200 С – 8 min. | |
50 |
Solution of spazmolitin of 0.5 %; 1 % |
Spazmolitin 5 g; 10 g | 30 | In a dark place | 1200С – 8 min. |
51 | Solution of soluble streptocide 5%; 10 % |
Soluble streptocide (in terms of dry matter) 50 g; | 30 | In a dark place | 1200С – 8 min. |
52 |
Solution of trimecaine 0,25 %; 0,5 %; 1 %; 2 %; 5 % |
Trimecain (in terms of anhydrous) 2.5 g; 5 g; 10 g; | 30+ |
In a dark place | 1200С – 8 min. |
53 | "Trisol" solution |
Potassium chloride 1 g | 30 | 1200С – 8 min. | |
54 |
Solution of soluble furagin 0.1 % |
Furagin soluble 10 % C | 7 | In a dark place | 1000С – 30 min. |
55 | Solution "Chlosol" |
Potassium chloride 1.5 g | 30 | 1200С – 8 min. | |
56 |
Solution of sodium ethazol 10 %; 20 % |
Ethazol-sodium (in terms of dry matter) 100 g; 200 g | 180 | In a dark place | 1200С – 8 min. |
57 | Solution of ephedrine hydrochloride 2 %; 3 %; 5 % |
Ephedrine hydrochloride 20 g; 30 g; 50 g | 30 | In a dark place | 1200С – 8 min. |
The sterilization holding time is indicated for solutions up to 100 milliliters. With an increase in the volume of the solution, the sterilization time is increased in accordance with Article "Sterilization" of the State Pharmacopoeia of the Republic of Kazakhstan. | |||||
2. Other sterile solutions | |||||
1 | 2 | 3 | 4 | 5 | 6 |
58 | Solution of glucose 50% (for intraamneal administration) |
Glucose (in terms of anhydrous) 500 g | 90 | 1200С – 8 min. | |
59 |
Solution of boric acid 2 % |
Boric acid 20 g | 30 | 1200С – 8 min. | |
60 | Solution of methyluracil 0.7 % |
Methyluracil 7 g | 30 | In a dark place | 1200С – 8 min. |
61 |
Solution of sodium tetraborate 20% in glycerin |
Sodium tetraborate 20 g | 30 | 1200С – 8 min. | |
62 |
Solution of sodium chloride 20 % |
Sodium chloride 200 g | 90 | 1200С – 8 min. | |
63 |
Solution of furatsilin 0,01 %; 0,02 % |
Furatsilin 0.1 g; 0.2 g | 30 | In a dark place | 1200С – 8 min. |
64 |
Solution of chlorhexidine bigluconate 0.02 %; |
Solution of chlorhexidine bigluconate 20 % - 1 ml; 2.5 ml | 90 | 1200С – 8 min. | |
65 | Solution of ethacridine lactate 0,1 % |
Ethacridine lactate 1 g | 30 | In a dark place | 1200С – 8 min. |
2. Eye drops, ophthalmic solutions for irrigation, concentrated solutions for manufacturing eye drops
№ п/п | Name and composition of the medicine | Expiration date in days at t | Storage conditions | Mode of sterilization (temperature, time) | Note | |
not higher than 250C | 3-50С | |||||
1 | 2 | 3 | 4 | 5 | 6 | 7 |
1. Eye drops | ||||||
1 |
Amidopyrine solution 2 % Composition: | 30 | 30 | In a dark place | 1200С – 8 min. | |
2 |
Atropine sulfate solution 0.25 %; 0.5 %; 1 % | 30 | In a dark place, in a lockable cabinet | 1000С – 30 min. | ||
3 |
Homatropin hydrobromide solution 0.5 %, 1 % | 30 | 30 | In a dark place, in a lockable cabinet | 1200С – 8 min. | |
4 |
Solution of dikain 0,25 %; 0,5 %; 1 % | 30 | In a lockable cabinet | 1000С – 30 min. | ||
5 |
Solution of dikain 0,5 %; 1 %; 2 %; 3 % | 120 | 0,5 % - 90 1 % - 30 | In a lockable cabinet | 1200С – 8 min. | A solution of 0.5% dikain is prepared without a stabilizer. Solution of dikain 2 % - 3 % cannot be stored in the refrigerator |
6 |
Dikain 0.05 g | 30 | 30 | In a lockable cabinet | 1200С – 8 min. | |
7 |
Dikain 0.05 g | 30 | 30 | In a dark place, in a lockable cabinet | 1200С – 8 min. |
After sterilization and cooling of a solution containing dikain, boric acid, and zinc sulfate, resorcinol is added under aseptic conditions |
8 |
Solution of diphenhydramine 0.25 %; 0.5 % | 90 | 90 | In a dark place | 1200С – 8 min. | |
9 |
Diphenhydramine 0.02 g | 30 | In a dark place | 1200С – 8 min. | ||
10 |
Potassium iodide solution 3 % | 30 | 30 | In a dark place | 1200С – 8 min. | |
11 |
Potassium iodide 0.05 g | 90 | 90 | In a dark place | 1200С – 8 min. | |
12 |
Solution of calcium chloride 3 % | 30 | 1200С – 8 min. | |||
13 |
Solution of ascorbic acid 0.2 % | 2 | 7 | In a dark place | 1000С – 30 min. | |
14 |
Solution of clonidine 0.125 %; 0.25 %; 0.5 % | 90 | 90 | In a dark place | 1200С – 8 min. | |
15 |
Solution of collargol 2 %; 3 % | 30 | 30 | In a dark place | Prepared under aseptic conditions | The solution can be filtered through a paper deashed filter |
16 |
Solution of levomycetin 0.2 % | 7 | 7 | In a dark place | 1000С – 30 min. | |
17 |
Levomycetin 0.01 g | 7 | 30 | In a dark place | 1000С – 30 min. | |
18 |
Levomycetin 0.02 g | 15 | In a dark place | 1000С – 30 min. | After sterilization and cooling of a solution containing levomycetin, boric acid, and zinc sulfate, resorcinol is added under aseptic conditions. | |
19 |
Mezaton 0.02 g | 7 | 30 | In a dark place | 1200С – 8 min. | |
20 |
Solution of mezaton 1 %; 2 % | 7 | In a dark place | 1200С – 8 min. | ||
21 |
Solution of mezaton 1 % | 30 | 30 | In a dark place | 1200С – 8 min. | |
22 |
Sodium bicarbonate 0.05 g | 30 | 30 | 1200С – 8 min. | ||
23 |
Solution of sodium iodide 3 % | 30 | 30 | In a dark place | 1000С – 30 min. | |
24 |
Sodium iodide 0.4 g | 30 | 30 | In a dark place | 1000С – 30 min. | |
25 |
Solution of novocaine 1 % | 30 | 30 | In a dark place | 1000С – 30 min. | |
26 |
Novocain 0.05 g | 10 | 30 | In a dark place | 1000С – 30 min. | After sterilization and cooling of a solution containing novocaine, boric acid, and zinc sulfate, resorcinol is added under aseptic conditions |
27 |
Novocaine 0.05 g | 10 | 20 | In a dark place | 1000С – 30 min. | After sterilization and cooling of a solution containing novocaine, boric acid, and zinc sulfate, resorcinol and a solution of epinephrine hydrochloride are added under aseptic conditions |
28 |
Solution of norsulfazol sodium 10 % | 10 | 30 | In a dark place | 1200С – 8 min. | It is necessary to put non-varnished cellophane (GOST 7730 -74) under the cork, washed with purified water |
29 |
Pilocarpine hydrochloride solution 1 %; 2 %; 4 %; 6 % | 30 | 30 | In a dark place, in a lockable cabinet | 1200С – 8 min. | |
30 |
Pilocarpine hydrochloride 0.1 g | 30 | In a dark place, in a lockable cabinet | 1200С – 8 min. | ||
31 |
Solution of riboflavin 0,02 % | 90 | 30 | In a dark place | 1200С – 8 min. | |
32 |
Riboflavin 0.001 g | 2 | 7 | In a dark place | 1000С – 30 min. | |
33 |
Riboflavin 0.002 g | 2 | 7 | In a dark place | 1000С – 30 min. | |
34 |
Riboflavin 0.002 g | 30 | 30 | In a dark place | 1000С – 30 min. | |
35 |
Riboflavin 0.002 g | 30 | 30 | In a dark place | 1000С – 30 min. | |
36 |
Riboflavin 0.002 g | 7 | 30 | In a dark place | 1000С – 30 min. | |
37 |
Riboflavin 0.002 g ascorbic acid 0.02 g | 7 | 30 | In a dark place | 1000С – 30 min. | |
38 |
Solution of scopolamine hydrobromide 0.1 %; 0.25 % | 30 | In a dark place, in a lockable cabinet | 1000С – 30 min. | ||
39 |
Solution of sulfapiridazin sodium 10 %; 20 % | 30 | 30 | In a dark place | 1200С – 8 min. | |
40 |
Solution of sulfacyl-sodium 20 % | 30 | In a dark place | 100оС – 30 min. | ||
41 |
Solution of sulfacyl-sodium 10 %; 20 %; 30 % | 30 | 30 | In a dark place | 1200С – 8 min. | The solution can be used for instillation into the eyes of newborn children. |
42 |
Solution of fetanol 3 %; 5 % |
2 (3 % solution) | 15 | In a dark place | 1200С – 8 min. | |
43 |
Solution of fetanol 3 % | 30 | 30 | In a dark place | 1200С – 8 min. | |
44 |
Solution of physostigmine salicylate 0,25 % | 30 | 30 | In a dark place, in a lockable cabinet | 1200С – 8 мин | |
45 |
Solution of fluorescein-sodium 0.5 % | 30 | 30 | In a dark place | 1200С – 8 мин | |
46 |
Solution of furatsilin of 0.02 % | 30 | 30 | In a dark place | 1200С – 8 min. | |
47 |
Solution of quinine hydrochloride 1 % | 120 | 120 | In a dark place | 1200С – 8 min. | |
48 |
Zinc sulfate 0.03 g | 30 | In a dark place | 1000С – 30 min. | ||
49 |
Zinc sulfate 0.025 g | 30 | In a dark place | 1000С – 30 min. | ||
50 |
Zinc sulfate 0.025 | 30 | 1200С – 8 min. | |||
51 |
Solution of ethylmorphine hydrochloride 2 % | 30 | 30 | In a dark place, in a lockable cabinet | 1000С – 30 min. | |
52 |
Solution of ephedrine hydrochloride 3 % | 30 | 30 | In a dark place | 1200С – 8 min. | |
2. Ophthalmic solutions for irrigation | ||||||
53 |
Saline ophthalmic solution | 30 | 1200С – 8 min. | Used for microsurgical operations on the eyes. | ||
54 |
Saline ophthalmic solution (with magnesium chloride) | 30 | 1200С – 8 min. | Used for microsurgical operations on the eyes. | ||
3. Concentrated solutions for manufacturing eye drops | ||||||
55 | Solution of potassium iodide 20 % | 30 | In a dark place | 1200С – 8 min. | ||
56 |
Solution of ascorbic acid 2 %; 5 %; 10 % | 5 | 30 | In a dark place | 1000С – 30 min. | The solution is manufactured on purified fresh boiled water. When filling the solution, the vials are filled to the top. |
57 | Solution of boric acid 4 % | 30 | 1200С – 8 min. | |||
58 | Solution of sodium thiosulfate 1 % | 30 | 1000С – 30 min. | |||
59 | Solution of riboflavin 0,02 % | 90 | 30 | In a dark place | 1200С – 8 min. | |
60 |
Riboflavin 0.02 g | 5 | 30 | In a dark place | 1000С – 30 min. | When filling the solution, the vials are filled to the top. |
61 |
Riboflavin 0.02 g | 30 | In a dark place | 1000С – 30 min. | ||
62 |
Riboflavin 0.02 g | 30 | In a dark place | 100С – 30 min. | ||
63 | Solution of zinc sulfate, 1% or 2 % | 30 | 1200С – 8 min. | |||
64 | Slution of citral 0,02 % | 2 | In a dark place | Manufactured in aseptic conditions on sterile purified water | ||
Opened vials with eye drop concentrates are used during the day. | ||||||
3. Medicines for newborns
№ п/п | Name and composition of the medicine | Expiration date in days at t not higher than 250C) | Storage conditions | Mode of sterilization (temperature, time) | Note |
1 | 2 | 3 | 4 | 5 | 6 |
1. Solutions for internal use | |||||
1 | Purified water | 30 | 1200С – 8 min. | ||
2 | Solution of glucose 5 % 10 % 25 % | 30 | 1200С – 8 min. | Prepare without stabilizer | |
3 |
Solution of glucose 5 % - 100 ml | 5 | In a dark place | 1000С – 30 min. | Prepared on purified freshly boiled water. When packing, the vials are filled to the top |
4 |
Solution of glucose 10 % or 20 % - 100 ml | 30 | In a dark place | 1200С – 8 min. | |
5 | Solution of dibazol 0,01 % | 30 | 1200С – 8 min. | ||
6 | Solution of dimedrol 0.02 % | 30 | In a dark place | 1200С – 8 min. | Dimedrol solution should be used only at a concentration of 0.02 % in a 10 ml pack. In a maternity hospital, you should refrain from using dimedrol solutions, given its pronounced sedative effect, depressing effect on the central nervous system and the possibility of intoxication |
7 | Solution of potassium acetate of 0.5 % | 30 | 1200С – 8 min. | ||
8 | Solution of potassium iodide 0.5 % | 30 | In a dark place | 1200С – 8 min. | Packing of the solution does not exceed 20 ml. |
9 | Solution of calcium gluconate 1 %; 3 %; 5 % | 7 | 1200С – 8 min. | Dissolve in hot water. | |
10 | Solution of calcium lactate 3 %; 5 % | 30 | 1200С – 8 min. | Prepare taking into account the actual moisture content in the medicine. | |
11 |
Solution of calcium chloride 3 % | 30 | 1200С – 8 min. | For preparation of the solution, it is advisable to use 10-50 % concentrate. | |
12 |
Solution of ascorbic acid 1 % | 5 | In a dark place | 1000С – 30 min. | Prepared on freshly boiled purified water. When packing, the vials are filled to the top. |
13 | Solution of glutamic acid 1 % | 30 | In a dark place | 1200С – 8 min. | |
14 | Solution of nicotinic acid 0.05 % | 30 | In a dark place | 1200С – 8 min. | |
15 |
Solution of hydrochloric acid 1 % | 30 | 1200С – 8 min. | When preparing, diluted hydrochloric acid is used (8.2-8.4 % GF X Article 18), taking it as 100 % | |
16 | Solution of caffeine-sodium benzoate 1 % | 30 | 1200С – 8 min. | ||
17 |
Solution of caffeine-sodium benzoate 0.25 g or 0.5 g | 30 | In a dark place | 1200С – 8 min. | |
18 |
Citric acid solution 1 g | 30 | 1200С – 8 min. | ||
19 |
Solution of magnesium sulfate 5 %; 10 %; | 30 | 1200С – 8 min. | ||
20 | Solution of sodium bromide 1 % | 30 | In a dark place | 1200С – 8 мин | |
21 | Solution of sodium chloride 0.9 % | 30 | 1200С – 8 min. | ||
22 |
Solution of Novocaine 0.5 g | 30 | In a dark place | 1200С – 8 min. | |
23 | Solution of pyridoxine hydrochloride 0.2 % | 30 | In a dark place | 1200С – 8 min. | |
24 | Solution of aminophylline of 0.05 %; 0,5 % | 15 | In a dark place | 1200С – 8 min. | |
Solutions for internal use for newborns are prepared with purified water. | |||||
2. Solutions, oils for external use | |||||
25 | Solution of Diamond green alcohol 1 % | 2 years | |||
26 |
Solution of potassium permanganate 5 % | 2 | In a dark place | Prepared under aseptic conditions | The solution is prepared in sterile purified water and poured into sterile vials. |
27 | Solution of collargol 2 % | 30 | In a dark place | Prepared under aseptic conditions | The solution is prepared in sterile purified water and poured into sterile vials. |
28 | Solution of sodium tetraborate 10% in glycerin | 30 | 1200С – 8 min. | ||
29 |
Solution of hydrogen peroxide 3 % | 15 | In a dark place | Prepared under aseptic conditions | The solution is prepared on sterile purified water, poured into sterile vials, capped with polyethylene plugs and screw caps. |
30 |
Furatsilin 0.02 g | 30 | 1200С – 8 min. | ||
31 | Solution of ethacridine lactate 0,1 % | 30 | In a dark place | 1200С – 8 min. | |
32 |
Peach oil | 30 | In a cool dark place | 1800С – 30 min. | Oils are sterilized in bottles for blood with a capacity of 50 ml, capped with rubber plugs of the brand IR – 21 for running-in. The use of plugs of brand 25 P (red) is not recommended. |
33 | Olive oil | 30 | In a cool dark place | 1800С – 30 min. | |
34 |
Sunflower oil | 30 | In a cool dark place | 1800С – 30 min. | |
35 | Vaseline oil | 30 | In a cool dark place | 1800С – 30 min. | |
3. Eye drops | |||||
36 | Solution of collargol 2 %; 3 % | 30 | In a dark place | Prepared under aseptic conditions | The solution can be filtered through a paper deashed filter |
37 |
Solution of sulfacyl-sodium 10 %; 20 %; 30 % | 30 | In a dark place | 1200С – 8 min. | |
Solution of hydrochloric acid 1 M 0.035 ml | |||||
4. Powders | |||||
38 |
Dibasol 0.001 g. | 90 | In a dark place | Prepared under aseptic conditions | |
39 |
Diphenhydramine is 0.002 g. | 90 | In a dark place | Prepared under aseptic conditions | |
40 |
Phenobarbital 0.002 g or 0.005 g | 90 | In a dark place | Prepared under aseptic conditions | |
41 |
Eufillina 0.003 g | 20 | In a dark place | Prepared under aseptic conditions | It is forbidden to replace sugar in powders with eufillin to glucose |
42 | Powder xeroform 10.0 g | 15 | In a dark place | 1800С – 30 min. | Sterilized in clear form. The vials are corked with treated rubber stoppers for running-in under aseptic conditions. |
5. Ointments | |||||
43. |
Tannin ointment 1 % | 20 | In a cool dark place | Prepared under aseptic conditions | Tannin is dissolved in a minimum amount of water and mixed with a sterile base. The base is sterilized at a temperature of 1800C-30 min. |
44 |
Tannin ointment 5 % | 20 | In a cool dark place | Prepared under aseptic conditions | Tannin is dissolved in a minimum amount of water and mixed with a sterile base. The base is sterilized at a temperature of 1800C-30 min. |
4. Ointments
№ п/п | Name and composition of the dosage form | Expiration date in days | Storage 30-50С | Sterilization conditions | Note |
1 | 2 | 3 | 4 | 5 | 6 |
1. Ointments | |||||
1 |
Ointment containing analgin and sodium citrate | 90 | In a dark place | ||
2 |
Diphenhydramine ointment 5 % | 30 | In a dark place | This composition of base should be used if the base is not specified when prescribing ointment dimedrol 5%. It has a surface effect. | |
3 |
Diphenhydramine ointment 5 % | 30 | In a dark place | It has a penetrating, resorptive effect. | |
4 |
Theophylline ointment 10 % | 1 year | In a dark place | ||
5 |
Furacillin ointment 0.2 % | 30 | In a dark place | ||
2. Eye ointments | |||||
6 |
Base for eye ointments 100 g | 30 | In a dark place | ||
7 |
Pilocarpine ointment 1 % or 2 % | 30 | In a dark place, in a lockable cabinet | Prepared under aseptic conditions | |
8 |
Thiamine ointment 0.5 % or 1% | 30 | In a dark place | Prepared under aseptic conditions | |
The base for eye ointments is obtained by fusing anhydrous lanolin and vaseline varieties for eye ointments in a porcelain cup when heated in a water bath. The molten base is filtered through several layers of gauze, packed in dry sterilized glass jars, tied with parchment paper and sterilized in an air sterilizer at a temperature of 180 ° C for 30-40 minutes or at a temperature of 200 ° C for 15-25 minutes, depending on the volume of the ointment. | |||||
5. Powders
№ п/п | Name, composition | Expiration date in days at t not higher 250С | Storage conditions | Sterilization mode | Note |
1 | 2 | 3 | 4 | 5 | 6 |
1 |
Anti-inflammatory and antacid powders | 1 year | In a dry, dark place | ||
2 |
Dibasol 0,003; 0,005 g; 0.008 g | 90 | In a dry, dark place | Prepared under aseptic conditions | For children |
3 |
Diphenhydramine 0.005 g | 90 | In a dry, dark place | Prepared under aseptic conditions | For children |
4 |
Diphenhydramine 0.005 g. | 1 year | In a dry, dark place | Prepared under aseptic conditions | For children |
5 |
Calcium gluconate 0.05 g. | 1 year | In a dry place | Prepared under aseptic conditions | For children |
6 |
Calcium gluconate | 1 year | In a dry place | Prepared under aseptic conditions | For children |
6. Mixtures and solutions for internal use
№ п/п | Name, composition | Expiration date in days at t0 | Storage conditions | Note | |
not higher 250С | 3-50С | ||||
1 | 2 | 3 | 4 | 5 | 6 |
1 | Quater mixture Composition: rhizome infusion with valerian roots of 10 g and mint leaves of 4 g-200 ml Sodium bromide 3 g | 10 | In a dark place | ||
Amidopyrine 0.6 g Caffeine-sodium benzoate 0.4 g Magnesium sulfate 0.8 g | |||||
2 | Infusion of thermopsis herb from 0.6 g-200 ml Sodium bicarbonate Sodium benzoate 4 g | 10 | In a dark place | ||
3 | Solution of hydrochloric acid 1 % - 100 ml Pepsin 2.0 | 10 | |||
4 | Solution of hydrochloric acid 1 % or 2 % | 10 | |||
5 | Solution of potassium iodide 0.25 % | 10 | In orange glass vials In a dark place | ||
6 | Solution of novocaine 0,25 % or 0,5 % | 10 | In orange glass vials In a dark place | ||
7 | Solution of magnesium sulfate 10 %; 25 %; 33 %; 50 % | 15 | |||
8 | Solution of calcium chloride 5% or 10% | 10 | |||
9 | Ringer's solution Composition: Sodium chloride 0.9 g Sodium bicarbonate Potassium chloride Calcium chloride 0.02 g Purified water up to 100 ml | 5 | 10 | ||
10 | Mint water | 30 | |||
11 | Dill water | 30 | |||
7. Concentrated solutions for manufacturing liquid medicines
№ п/п | Name, composition | Expiration date in days at t0 | Storage conditions | Note | |
not higher 250С | 3-50С | ||||
1 | 2 | 3 | 4 | 5 | 6 |
1 | Solution of ammonium chloride 20 % | 15 | |||
2 | Solution of sodium barbital 10 % | 10 | |||
3 | Solution of hexamethylenetetramine 10 %; 20 %; 40 % | 20 | |||
4 | Solution of glucose 5 % | 2 | |||
5 | Solution of glucose 10 %; 20 %; 40 %; 50 % | 4 | 10 | ||
6 | Solution of potassium bromide 20 % | 20 | In a dark place | ||
7 | Solution of potassium iodide 20 % | 15 | In a dark place | ||
8 | Solution of calcium chloride; 20 % | 10 | |||
9 | Solution of calcium chloride 50 % | 30 | |||
10 | Solution of ascorbic acid 5 % | 5 | |||
11 | Solution of hydrochloric acid 10 % | 30 | |||
12 | Solution of caffeine-sodium benzoate 5 % | 7 | 15 | ||
13 | Solution of caffeine-sodium benzoate 20 % | 20 | |||
14 | Solution of magnesium sulfate 10 %; 25 %; 50 % | 15 | |||
15 | Solution of sodium benzoate 10 % | 20 | |||
16 | Solution of sodium bromide 20 % | 20 | In a dark place | ||
17 | Solution of sodium bicarbonate 5 % | 4 | 10 | ||
18 | Solution of salicylate sodium 40 % | 20 | In a dark place | ||
19 | Solution of temisal 10 % | 10 | In a dark place | ||
20 | Solution of chloral hydrate 10 % | 5 | In a dark place | ||
21 | Solution of chloral hydrate 20 % | 15 | In a dark place | ||
8. Nose drops and solutions for external use
№ п/п | Name, composition | Expiration date in days at t0 | Storage conditions | Note | |
not higher 250С | 3-50С | ||||
1 | 2 | 3 | 4 | 5 | 6 |
1 |
Dimedrol 0.01 g | 30 | In a dark place | ||
2 |
Solution of boric acid 2 % with diphenhydramine 1 % | 30 | In a dark place | ||
3 |
Solution of boric acid 2% 10 ml | 10 | 30 | In a dark place | |
4 | Solution of collargol 3 % | 30 | In a dark place | ||
5 | Solution of protargol 2 % | 30 | In a dark place | ||
6 |
Lugol's solution of 0.25% on the glycerol | 30 |
In orange glass vials | ||
7 |
Solution of sodium tetraborate 20% in glycerin | 30 | |||
8 |
Solution of hydrogen peroxide 3 % | 2 years | In a cool, dark place | ||
9 | Solution furacilin of 0.02 % | 20 | In a dark place | ||
10 |
Solution of streptotsid soluble 0.8% with furacilin 0,01 % | 30 | In a dark place | ||
9. Semi-finished products for manufacturing external liquids, nose drops, powders and ointments
№ п/п | Name, composition | Expiration date in days at t0 | Storage conditions | Note | |
not higher 250С | 3-50С | ||||
1 | 2 | 3 | 4 | 5 | 6 |
1 | Solution of dimedrol 1 % | 20 | In a dark place | ||
2 | Solution of boric acid 2 % | 15 | 30 | ||
3 | Solution of sodium thiosulfate 60 % | 15 | |||
4 | Solution of sodium chloride 0.9 % | 7 | 15 | ||
5 | Solution of soluble streptocide 0.8 % | 2 | 10 | In a dark place | |
6 | Solution of ethacridine lactate 0,02 %; 0,05 %; 0,1 %; 0,2 % | 15 | |||
7 | Solution of ephedrine hydrochloride 10 % | 15 | In a dark place | ||
8 | Zinc oxide talc equally | 30 | |||
9 | Zinc oxide talc starch equally | 30 | |||
10 |
Lanolin water | 15 | In a dark place | ||
11 |
Lanolin water | 15 | In a dark place | ||
12 |
Anhydrous lanolin | 5 | In a dark place | ||
10. Homeopathic granules and water-alcohol dilutions (potencies)
№ п/п | Name, composition | Expiration date in days at t0 | Storage conditions | Note | |
not higher 250С | 3-50С | ||||
1 | 2 | 3 | 4 | 5 | 6 |
1 | Homeopathic granules | 2 years | In a dry, dark place | ||
2 | Intermediate aqueous-alcoholic homeopathic dilutions (potencies) | 6 months | In a dark place, in a well corked container | ||
11. Expiration dates of other medicines
№ п/п | Medicine | Expiration dated no more than (days) |
1 | Aqueous solutions containing benzylpenicillin and glucose | 1 |
2 | Eye drops | 2 |
3 | Infusions, decoctions, mucus | 2 |
4 | Emulsions, suspensions | 3 |
5 | Injection solutions and infusions | 2 |
6 | Other medicines | 10 |
| Appendix 4 to the Rules for manufacturing medicines and medical products form |
Journal of registration control results for individual stages of manufacturing solutions for injections and infusions
Date | № п/п (it is also analysis number) | Prescription №, name of medical organization | Initial medicines | Name and volume of the manufactured solution | Signature of the manufacturer of the solution | Filtration and packing (bottling) | ||
name | number | |||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Continuation of the table
Signature of the packer | Signature of the primary inspector of mechanical additive | Sterilization | Signature of the secondary inspector of mechanical additive | № of analyses before and after sterilization (indicated by a fraction) |
Number of bottles (vials) of finished products received for delivery | Signature of the person who allowed the finished product to delivery (responsible person - head of the department, pharmacist) | |||
Temperature |
Time | Thermotest | Signature of the sterilizer | ||||||
10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 |
| Appendix 5 to the Rules for manufacturing medicines and medical products form |
Journal of registration of sterilization mode of initial medicinal substances, manufactured medicinal products, auxiliary materials and utensils
Date | № п/п |
series №, | Name | Number | Sterilization conditions | Thermotest | Signature of the sterilizer | ||
before |
after | temperature |
time | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
