DEFINITION TYPES AND STANDARD TESTS:
Injectable Preparations are also called as parenteral preparations. These are sterile preparations. Injectable preparations are sterile preparations and are administered by injection, infusion or implantation.
Injectable Preparations should be prepared by methods which ensures the Sterility, avoids contamination of foreign matters, pyrogens, Micro-organisms and Bacterial Endotoxins. Water for injection is most commonly used as vehicle for injectables solutions and suspensions. Other suitable vehicles may be used provided they are safe in the volume of injection administered and it should not interfere with the therapeutic efficacy of formulation. Other additives like Buffers, Antioxidants, Chelating agent, Preservatives and stabilizer etc., can be added to preparations. Colouring agents are not added solely for colouring purpose of finished product.
Aqueous preparations administered by Subcutaneous, Intradermal, IM, IV route are made isotonic with blood by addition of Sodium Chloride or such suitable agent. Buffering agents are not used for preparations used for intraocular or intra cardiac injection or in products that may gain access to the cerebrospinal fluid. Preservatives are added in multi dose containers. Preservative should not be added when the volume to be injected as a single dose exceeds as
Each final container of injectable preparation shall be inspected individually.
There are five main types of injectable preparations:
2. Powder for injection.
3. Intravenous Infusion.
4. Concentrated solutions for injections.
Injections are sterile solutions, emulsions or suspensions prepared by dissolving emulsifying or suspending the active ingredients and other additives in water for injection or other suitable non aqueous vehicle or in mixture of two, if they are miscible.
1. Particulate Matter: Comply with limit test for Particular matters.
2. Uniformity of Content: The Preparation being examined complies with the test if in the total samples of 30 containers not more than one individual value is outside the limits 85% to 115% and none is out side the limits 75% to 125% of the average values.
This test is not applicable for suspensions for injection containing Multi-vitamins and Trace
3. Extractable Volumes:
a) Volume Less than 5ml: The average content of 5 containers is not less than the nominal volume and not more than 115% of the nominal volumes.
b) Volume more than 5ml: The average content of 3 containers is not less than the nominal volume and not more than 110% of the nominal volumes.
4. Sterility: Should comply with the test for Sterility.
5. Pyrogen Test: Comply with the Test for Pyrogen and Test for Bacterial Endotoxins.
6. pH: Comply with the specifications.
7. Weight per MI: Comply with specifications.
8. Leak test for Ampoules: No Leak ampoules observed.
2. POWDER FOR INJECTION:
Powder for injections are sterile solid substances (including freeze dried material) which are distributed in their final containers which, when shaken with the prescribed volume of the appropriate sterile liquid, rapidly form clear and practically particle-free solutions or uniform suspension.
1. Uniformity of content: as described under injections.
2. Uniformity of Weight: This test is not applicable for powder for injection that are required to comply with the test for Uniformity of content of all active ingredients.
Test is complies when, not more than two weight deviate from the average weight by more than 10% and non deviates by more than 20% from 20 samples.
3. Sterility test: It should comply with the test for the sterility.
4. Loss on drying: It should comply with specifications.
3. INTRAVENOUS INFUSION:
These are sterile aqueous solutions or emulsions with water as continuous phase.
They are free from pyrogens or Bacterial Endotoxins, they are usually made isotonic with blood and they don’t contain any antimicrobial preservatives.
1. Particulate Matter: Intravenous infusions that are solutions and supplied in containers with a nominal content of 100ml or more comply with test for particulate matter.
2. Sterility: Comply with test for sterility.
3. Pyrogen: Comply with test for pyrogens if test for Bacterial Endotoxin is not prescribed.
4. Assay for Active ingredients: Comply with specifications.
5. pH: Comply with specifications.
6. Weight per ml: Comply with specifications.
7. Filled / Extractable Volumes: Comply with specifications.
4. CONCENTRATED SOLUTIONS FOR INJECTIONS:
Concentrated solutions for injections are sterile solutions that are intended for administration by injection or by IV infusion only after dilution with suitable dilution with a suitable liquid. After dilutions these preparations should comply with the requirements of tests for injection or intravenous infusions as appropriate.
Implants are sterile solid preparations of size and shape for implantation into body tissues so as to release active ingredient over an extended period of time.
1. Sterility: Comply with test for sterility.
2. Assay content of active ingredients: Comply with specifications.
3. Average Weight of implants: Comply with specifications.
4. Rate of Release (Dissolution test): Comply with designed period of release.
5. Hardness: Comply with specifications.
6. Other tests:
Classification of Parenteral Preparation based on Preparation:
1. Small Volume Parenteral (SVP).
2. Large Volume Parenteral (LVP).
1. Small Volume Parenteral:
a. Preparation of Small Volume Parenteral Solutions.
b. Preparation of Typical Suspension Formula.
c. Preparation of Typical Freeze dried Powdered Formula.
d. Preparation of Typical Sterile Dry fills powder for constitutions.
e. Preparation of Ophthalmic Preparations.
1) Preparation of Ophthalmic Solutions.
2) Preparation of Ophthalmic Suspensions.
3) Preparation of Ophthalmic Gels.
4) Preparation of Ophthalmic Ointments.
5) Preparation of Intraocular Irrigating Solutions.
f. Preparations of Inramammary Infusions (Gels, Ointments).
g. Preparation of Genetically Engineered or Biotechnology Products.
(Vaccines and Toxides, Recombinant DNA Technology Products)
h. Preparations of Liposome are Lipid Product.
2. Large Volume Parenteral:
Preparations containing nominal volumes more than 100ml contents.