Teledyne Leeman Labs manufactures Mercury Analyzers and Inductively Couple Plasma Spectrometers designed to easily meet the performance requirements outlined in the proposed new Elemental Impurities <232> in United States Pharmacopeia National Formulary (USP-NF).
Intended to replace the outdated Heavy Metals <231>, the proposed new chapter requires that drug manufacturers test their products for what are designated as Class 1 and 2 Elements.
The Class 1 elements are As, Pb, Hg and Cd and because of their toxicity should not be present in any drug substance or product. They must be measured in all products and shown to be essentially absent. Class 2 elements are of lower toxicity and are those that are added during the manufacturing process, as a catalyst, for example. Only elements actually added in the manufacturing process must be measured in the product.
How a manufacturer demonstrates compliance with the limits is up to the manufacturer. ICP is considered a referee procedure. Methods such as Cold Vapor Atomic Absorption or Atomic Fluorescence (CVAAS or CVAFS) Mercury would also be acceptable.
In addition to Elemental impurities applications, Teledyne Leeman's instruments are ideal in a research setting. Powerful and flexible, their unique features will meet the needs of the most demanding research tasks.
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