All drug products sold in the U.S. will have to comply with the limits set by USP<232>, and drug substances and excipients will have to be tested and reported for elemental impurities. January 1 of this year USP has established as the date of applicability of the Elemental Impurities Limits General Chapters.   Under GMP drug quality and regulatory requirements, elemental impurities will have to be monitored for all existing drug products, APIs, and excipients – not just for the 15 elemental impurities of USP<232>, but for the full 24 elemental impurities of Q3D.

Pine Lake Laboratories can assist you in meeting this requirement.

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