Storage conditions of drugs

The temperature of the refrigerator should be in the range of 2C to 8C.

Rakesh Dahiya

December 7, 2022

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Medical Store Pharmacy Medicine Pharmacist — Picture: Pixabay

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Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

Storage conditions of drugs

Medical Store Pharmacy — Picture: Pixabay

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Storage conditions and limit

Storage Condition	Limit
Room Temperature	20° to 25°
Cool Storage Condition	8° to 15°
Cold Storage condition	2° to 8°
Fridge Storage condition	-4° to 2°

List of Refrigerated Drugs and Medicines

Drugs/medicines that are required to be kept in the refrigerator are called refrigerated drugs/medicines.

The temperature of the refrigerator should be in the range of 2C to 8C.

This temperature is required for maintaining stability and potency throughout the drug’s life.

These drugs/medicines are very sensitive in nature and require some extra care while manufacturing, transportation, stocking, prescribing, etc.

There are some other drugs that are required to be stored at temperatures of -15C to -20C.

These drugs/medicines are covered under Schedule C of the Drug and Cosmetic Act & Rules, 1940.

The storage conditions are to be mentioned on the labels of the drugs/medicines.

The list of refrigerated drugs is as follows:

Sera
Serum proteins
Vaccines.
Toxins
Antigen

Antitoxins
Neo-arsphenamine and analogous substances are used for the specific treatment of infectious diseases.
Insulin
Pituitary (Posterior Lobe) Extract
Adrenaline and Solutions of Salts of Adrenaline

Specific Antibiotics and preparations (Parenterals and Non-Parenterals)
Bacteriophages
Ophthalmic preparations
Sterile Disposable Devices for single use only
Some plant extracts like digitalis, ergotamine etc

Definitions of Storage Conditions As Per IP 96

1. COLD: Any temperature not exceeding 8°C and usually between 2°C to 8°C. A refrigerator is a cold place in which the temperature is maintained thermostatically between 2°C to 8°C.

2. COOL: Any temperature between 8°C and 25°C. An article, for which storage in a cool place is directed may alternately, be stored in a refrigerator unless otherwise specified in the individual monograph.

3. ROOM TEMPERATURE: The temperature prevailing in a working area.

4. WARM: Any temperature between 30°C and 40°C.

5. EXCESSIVE HEAT: Any temperature above 40°C.

6. LIGHT RESISTANT CONTAINERS: A light-resistant container protects the content from the effect of actinic light by virtue of the specific properties of the material of which it is made.

7. WELL-CLOSED CONTAINER: A well-closed container protects the contents from contamination by extraneous liquid and from loss under normal conditions of handling, shipment, storage, and distribution.

Storage conditions of different drugs as per IP

1. In a Frozen State:	Ceftazidime Inj
2° to 8° C:	Antisera
	Biphasic Isophane Insulin Inj
	BCG Vaccine
	Carbenicillin Sodium Inj. [Biopence™ Carbelin™ Pyopen™]
	Carboprost Tromethamine Inj. USP [Endoprost™, Prostodin™]
	Desferrioxamine Mesylate Inj. [Desferal 0.5 g™]
	Dilzem™ Inj.
	Dinoprostone Gel [Cerviprime 0.5mg.™Primiprost™]
	Ergometrine Maleate Inj.
	Gas-Gangrene Antitoxin (Oedematiens)
	Gas-Gangrene Antitoxin (Perfringes)
	Gas-Gangrene Antitoxin (Septicum)
	Hepatitis B Virus Vaccine (H B Vac™ Enivac HB™ Engerrix B™
	Heppacine-B™ Shanvac-B™)
	Human Normal Immunoglobulin [Histaglobulin ™ (lyophillised)
	Insulin Inj. (e.g. Insuman ™ 50/50)
	Measles Vaccine, Live (M-Vac™)
	Methylergometrine Maleate Inj.
	Mixed Gas Gangrene Antitoxin
	Plague Vaccine
	Poliomyelitis Vaccine, Live (oral)[Polio Sabin™ Oral Polio™]
	Protamine Sulphate Inj.
	Rabies Anti-serum-Equine
	Rabies Immuno Globulin (Human) EP [Kamrab™]
	Rabies Vaccine Human (Neural Tissue)
	Rabies Vaccine, Human (Cell Culture)[Abhayrab™]
	Recombinant Streptokinase (r-Streptokinase) Inj. 1,500,000 IU
	Rho (D) Immune Globulin (Human) 50µg, 150µg, 300µg
	Rubell Vaccine Live BP [R-Vac™ (lyophillised)]
	Sandoglobulin™
	Schick Control
	Schick Test Toxin
	Scorpion Venom Antiserum
	Snake Venom Antiserum
	Soluble Insulin Inj.
	Streptokinase Inj. [Embokinase™ Kabikinase™ Streptase™]
	Succinylcholine Chloride Inj. [Midarine™ Scoline™]
	Tetanus Immunoglobulin BP (Human) [Tetglob™]
	Tetanus Vaccine (Adsorbed)
	Typhoid Paratyphoid A Vaccine
	Typhoid Vaccine Oral [Typhoral™]
	Typhoid Vaccine [Typhim VI™]
	Typhus Vaccine
	Vaccines
	Vasopressin Inj. [Petresin™]
	Vinblastine Sulphate Inj. [Cytoblastin™]
	Vincristine Sulphate Inj. [Cytocristn™ Vincristine™ Oncristine AQ™]
	Yellow Fever Vaccine, Live
3. Below 10° C:	Japanese Encephalitis Vaccine, Human (Mouse Brain)
	Methylprednisolone Acetate Inj.
4. At a temp. Not exceeding 20° C:	Chorionic Gonadotrophin Inj.
	(Pubergen 2000 IU ™)
	Urokinase™
5. Between 2° & 25° C:	Human Plasma Protein Fraction
6. Between 20° & 30° C:	Mannitol Inj.
7. In a Refrigerator:	Velocite ™ & Pregcolor ™ Test Kits
8. 23° or below:	Desferrioxamine Inj.
9. Store below 30°:	Dobutamine Inj. USP 50 mg/ml
	Propofol Inj.™
10. Store in Cool Place:	Heparin Inj.
	Morphine Inj.
11. To Be Stored Below 25° C:	Cefotaxime Sodium Inj.
	Cefuroxime Sodium Inj.
	Dopamine Hydrochloride Inj. USP [Dopasys™]
	Enoxaparin Sodium Inj.
	Human Chorionic Gonadotrophin [Profasi™]
	Human Normal Albumin Soln [Alburel™]
	Menotrophin (hMG)[Pergonal 75™]
	Meropenam Inj.
	Naloxone Inj. 400mcg/ml
	Nifedipine Sustained Release Tab (Calcigard-10 Retard Tab™)
	Urofolliotrophin (FSH) 75 IU [Metrodin 75]

PRECAUTIONS
1. Should not be allowed to freeze	Antisera Inj. Cortisone Acetate Inj.
	Fluorouracil Inj.
	Gas Gangrene Antitoxin (Oedematiens)
	Gas-Gangrene Antitoxin (Perfringens)
	Gas-Gangrene Antitoxin (Septicum)
	Hepatitis B Virus Vaccine [H B Vac™ Inj., Shanvac-B™]
	Histaglobulin™ [lyophillised]
	Insulins
	Methylprednisolone Acetate Inj.
	Mixed Gas-Gangrene Antitoxin
	Oxytocin Inj.
	Plague Vaccine
	Rabies Vaccine, Human (Neural Tissue)
	Scorpion Venom Antiserum
	Snake Venom Antiserum
	Succinylcholine Chloride Inj.
	Typhoid Paratyphoid A Vaccine
	Typhoid Vaccine
	Vaccines
2. Avoid Long Exposure above 30° C	Cyclophosphamide Inj.