Oral drug products fall into two main categories: solids and liquids. Solid oral drug products include but are not restricted to capsules, tablets, granules, and powders. Similarly, liquid oral drug products include but are not restricted to solutions, suspensions, and emulsions.
Drug Product Quality Test
Drug product quality tests for oral drug products fall into two categories: (1) universal tests that are applicable to all oral drug products and should be included in the monograph, and (2) specific tests should be considered for inclusion for specific types of oral products.
Universal Tests
- Description
- Identification
- Assay
- Impurities
Specific Tests for Tablets
- Volatile Content
- Disintegration
- Tablet Friability
- Tablet Breaking Force (Hardness)
- Uniformity of Dosage Units
Specific Tests for Capsules
- Volatile Content
- Disintegration
Specific Tests for Granules
- Volatile Content
- Disintegration
Specific Tests for Powders
- Minimum Fill
- Volatile Content
- pH
- Microbial limits
Specific Tests for Liquids
- Deliverable Volume
- Alcohol Determination
- pH
- Microbial Content
- Antioxidant
- Extractables
Drug Product Performance Test
Drug product performance tests assess product performance, which is a specific quality attribute typically linked to bioavailability and bioequivalence studies. It’s designed to assess in vitro drug release from dosage forms (e.g., Dissolution). For liquid oral drug products in solution, performance is considered optimal, and a monograph performance test is not included.
Related Articles:
- Product Quality Tests for Topical and Transdermal Drug Products
- Product Quality Tests for Injections and Implanted Drug Products
- Product Quality Tests for Mucosal Drug Products
- Product Quality Test for Inhalation and Nasal Drug Products
Reference: USP General Chapter <2>
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