Скачать или смотреть EVALUATION TESTS FOR SUPPOSITORIES( PART 4)

#Evaluation_tests_for_suppositories

1. General Introduction about Suppositories

   • ||SUPPOSITORIES|| General Introduction, Id...  

2. Classification of Suppositories bases

   • CLASSIFICATION OF SUPPOSITORY BASES II PART 2  

3. Preparation methods of Suppositories

   • PREPARATION METHODS OF SUPPOSITORIES( Part 3)  


QUALITY CONTROL procedures listed in the US
Pharmacopeia (USP30-NF25) for manufactured suppositories include identification, assay, and, in some cases, water content, residual solvent,
dissolution, and content uniformity:
1. Identification: Identification tests are commonly used for the identification and confirmation of official articles.
Assay: Assay and test procedures are used to determine compliance with the pharmacopeial standards of identity, strength, quality, and purity. Chromatographic methods are commonly used for detection and quantitation.
2. Dissolution: Dissolution testing is used to determine compliance with the dissolution requirements, if present in the individual monographs.
The test measures the rate and extent of a drug dissolving in a defined medium under defined conditions.
3. Content uniformity: Content uniformity is required in some monographs to ensure the consistency of dosage units. These dosage units should
have a drug substance content within a narrow range around the label claim. Weight variation and content uniformity testing involving groups and individual dosage units are used.