Rational limits for drug impurities

¹Drugs Standards Division, United States Pharmacopeial Convention Inc., Rockville, Maryland.

|January 1, 1990

Abstract:

The United States Pharmacopeia (USP) has developed policies on drug substance purity and organic volatile impurities. This paper will include the historical background and the scientific basis of these policies and will give several examples of how they are reflected in the tests that are included in USP monographs. Data on the types of analytical methods used in assessing the purity of compendial articles will also be presented.

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Abstract:

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