How to fix the specification limit for an unknown impurity for an API?

Question

Accepted Answer

To fix the specification limit for an unknown impurity in an API, conduct thorough analysis and consider regulatory guidelines.

Perform comprehensive analysis of the impurity to determine its identity, properties, and potential risks
Refer to regulatory guidelines and industry standards to establish acceptable limits for impurities
Consider the impact of the impurity on the quality, safety, and efficacy of the API
Collaborate with experts in analytical chemistry and toxicology to assess the impurity's potential harm
Conduct stability studies to evaluate the impurity's formation and degradation over time
Perform risk assessments to determine the acceptable levels of the impurity
Consider the impurity's potential impact on patients and the intended use of the API
Document the rationale behind the chosen specification limit and justify it to regulatory authorities

Accepted Answer

0.1% any known impurity

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