Medicine
A medicine specification is a detailed description of the quality standards that a pharmaceutical product or substance must meet to ensure its safety, efficacy, and quality. It outlines the tests, analytical procedures, and acceptance criteria that a product must pass to be considered acceptable for use. [1]
India
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A medicine specification typically includes information on the following:
Identity: The identity of the active pharmaceutical ingredient (API) and any excipients used in the product.
Purity: The purity of the API and any excipients, including limits for impurities.
Potency: The potency of the API, including limits for assay and content uniformity.
Performance: The performance characteristics of the product, such as dissolution rate and bioavailability.
Physical characteristics: The physical characteristics of the product, such as appearance, texture, and packaging.
Medicine specifications are developed and validated by pharmaceutical manufacturers and are subject to regulatory review and approval by agencies such as the FDA.
The International Conference on HaICH) has published guidelines for the development and validation of medicine specifications, including Q6A and Q6B
