Parenteral drug products include both injections and implanted drug products that are injected through the skin or other external boundary tissue, or implanted within the body to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions.
Injections may exist as either immediate- or extended-release dosage forms. Implanted parenteral drug products are long-acting dosage forms that provide continuous release of the active drug substance(s), often for periods of months to years. For systemic delivery, they may be placed subcutaneously; for local delivery, they may be placed in a specific region of the body. Routes of administration for parenteral drug products include intravenous, intraventricular, intra-arterial, intra-articular, subcutaneous, intramuscular, intrathecal, intracisternal, and intraocular.
Parenteral dosage forms include solutions, suspensions, emulsions, sterile powders for solutions and suspensions (including liposomes), implants (including microparticles), and products that consist of both a drug and a device such as drug-eluting stents.
Product Quality Tests for Parenteral Dosage Form
- Universal Tests
- Identification
- Assay
- Impurities
- Foreign and particulate matter
- Sterility
- Bacterial endotoxins
- Container content
- Packaging systems
- Container–closure integrity
- Labeling
- Specific Tests
- Uniformity of dosage units
- Vehicles and added substances
- Antimicrobial preservatives
- Water content
- Aluminum content
- Completeness and clarity of solutions
Product Quality Tests for Specific Parenteral Dosage Form
Solutions
- Universal Tests
- Specific Tests: Antimicrobial Preservatives
Sterile Powders for Solutions
- Universal Tests
- For constituted solutions: Uniformity of dosage units
- For dry cake: Loss on Drying, Water Determination, and Appearance
Suspensions
- Universal Tests
- Specific Tests: Uniformity of Dosage Units, Antimicrobial Preservatives
Liposomes
- Universal Tests
- Specific Tests: Globule Size Distribution in Lipid Injectable Emulsions
Sterile Powders for Suspensions
- Universal Tests
Emulsions
- Universal Tests
- Specific Tests: Globule Size Distribution in Lipid Injectable Emulsions
Implants
- Universal Tests
- Specific Tests: Uniformity of Dosage Units
In situ Gels
- Universal Tests
- Specific Tests: Antimicrobial Preservatives
Microparticles
- Universal Tests
- Specific Tests: Uniformity of Dosage Units, Water Content
Drug-Eluting Stents
- Universal Tests
- Specific Tests: Uniformity of Dosage Units, Biological Reactivity Tests, In Vivo
Reference: USP General Chapter 〈1〉
Related Articles: