Elemental Impurities

In an effort to improve and modernize the United States Pharmacopeial Convention’s (USP) General Chapter for Heavy Metals , USP has proposed the addition of two new General Chapters and one Supplemental General Chapter.

• <233> Elemental Impurities – Procedure
• <232> Elemental Impurities – Limits
• <2232> Elemental Contaminants in Dietary Supplements

The updated methodologies utilize modern technologies to provide better precision and yield higher recoveries. To comply with these changes, drug products will be required to fall within the proposed limits. General Chapters and will be made official in December, 2012, appearing in USP 35-NF 30 Supplement 2. The implementation date is proposed for May 1, 2014.

Who will have to comply?
•Medical Device

HylaPharm Utilizes Modern Instruments:
•Graphite AA
•Flame AA
•Cold Vapor AA