What is the specification limit for known impurities and unknown impurities and which guideline explains

Question

Accepted Answer

The specification limit for known and unknown impurities varies depending on the specific substance being tested.

The specification limit for known impurities is typically set by regulatory agencies or pharmacopoeias.
For example, the United States Pharmacopeia (USP) sets limits for known impurities in pharmaceutical substances.
The specification limit for unknown impurities is usually determined through method validation studies.
These studies involve analyzing samples of the substance and setting a limit based on the level of impurities detected.
Guidelines such as the International Conference on Harmonisation (ICH) provide recommendations for method validation and impurity testing.

Accepted Answer

Ichq6A explains and limits are 0.15 for known and 0.10 for unknown

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