A Simple and Unique Approach for Developing and Evaluating Products

Commonly pharmaceutical products are evaluated and developed based on four “quality” parameters/measurements: (1) Identity, to show that a product contains the expected drug; (2) assay, to show that a product contains expected amount of drug (dose); (3) Content Uniformity (CU), to establish that the dose or drug content in each unit varies within an expected range; (4) Dissolution/release, to show that the drug will be released from the product in an expected manner. All these tests are simple chemical tests based on solvent extractions, i.e. the drug is extracted from the product and measured using any of the quantitative techniques such as spectrophotometeric or chromatographic.  For complete article, click here.

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