Topically applied drug products fall into two general categories: (1) those applied to achieve local action and (2) those applied to achieve systemic effects after absorption through the skin into the blood circulation. They include, but are not restricted to creams, gels, ointments, pastes, suspensions, lotions, foams, sprays, aerosols, solutions, and transdermal patches.
Product Quality Tests
Universal Tests
- Description
- Identification
- Assay
- Impurities
Specific Tests
- Uniformity of Dosage Units
- Water Content
- Microbial Limits
- Antimicrobial Preservative Content
- Antioxidant Content
- Sterility
- pH
- Particle Size
Specific Tests for Ophthalmic Drug Products
- Sterility Tests
- Containers
- Metal Particles
- Leakage
Specific Tests for Topically Applied Semisolid Drug Products
- Apparent Viscosity
- Uniformity in Containers or Tubes
Specific Tests for Transdermal Delivery Systems
- Peel Adhesion Test
- Release Liner Peel Test
- Tack Test
- Leak Test
Reference: USP General Chapter 〈3〉