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List of Stability Tests for Pharmaceutical Dosage Forms
Solid Dosage Forms (Tablets, Capsules, Powders)
- Appearance: Visual inspection for color, shape, and physical integrity.
- Assay/Potency: Quantitative analysis of the active pharmaceutical ingredient (API) content.
- Dissolution/Disintegration: Evaluation of the rate of drug release.
- Hardness/Friability: Mechanical strength assessment of tablets and capsules.
- Uniformity of Dosage Units: Ensuring consistent distribution of API in a batch.
- Weight Variation: Assessment of the uniformity of tablet/capsule weights.
- Physical Characteristics: Including moisture content, particle size distribution, and flow properties.
- Related Substances/Impurities: Detection and quantification of impurities or degradation products.
Liquid Dosage Forms (Solutions, Suspensions, Emulsions)
- Appearance: Visual inspection for color, clarity, and physical characteristics.
- Assay/Potency: Quantitative analysis of API content.
- pH:
Measurement of the pH value.
Particle Size: For suspensions and emulsions, assessment of particle size distribution.
Centrifugation/Sedimentation: Evaluation of physical stability in suspensions.
Content Uniformity: Ensuring consistent API distribution in liquid preparations.
Chemical Stability: Detection of degradation products or changes in chemical properties.
Microbial Contamination: Microbiological assessment to ensure absence of microbial growth.
Semi-Solid Dosage Forms (Creams, Ointments, Gels)
- Appearance: Visual inspection for color, texture, and consistency.
- Assay/Potency: Quantitative analysis of API content.
- Viscosity/Rheological Properties: Measurement of flow characteristics.
- Spreadability: Assessment of ease of application.
- Homogeneity: Ensuring uniform distribution of API.
- Microbial Contamination: Microbiological assessment to ensure product safety.
- Chemical Stability: Detection of changes in chemical properties.
- Physical Changes: Including phase separation and creaming in emulsions.
Parenteral Dosage Forms (Injections, Infusions)
- Appearance: Visual inspection for color, clarity, and particulate matter.
- Assay/Potency: Quantitative analysis of API content.
- pH: Measurement of the pH value.
- Particulate Matter: Detection and quantification of foreign particles.
- Chemical Stability: Detection of degradation products.
- Container Integrity: Ensuring the integrity of vials or ampoules.
- Endotoxin Testing: Assessment of bacterial endotoxin contamination.
- Sterility: Microbiological assessment to ensure absence of microbial growth.
Remember that specific stability testing requirements may vary based on the type of dosage form, regulatory guidelines, and the nature of the drug product. It’s important to refer to relevant regulatory guidance and quality standards when designing and conducting stability tests.
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