Sign in Home Industry Customer service Order sample vessels Order forms Quality Contact Us ANALYSIS OF ELEMENTAL IMPURITIES Home › Medicines Analysis of elemental impurities and USP <232>, <233>, ICH Q3D and metal control of drugs Search analysis Sample type Analysis type Free search Clear Search analysis ANALYSIS OF ELEMENTAL IMPURITIES The new guidelines for elemental impurities , which are currently being finalized by the US Pharmacopoeia (USP) and ICH, present limit values and analytical methods for quantification of metals and catalyst elements in pharmaceuticals. Analysis of elemental impurities can be performed on the finished drug product or, for example, active drug ingredients (APIs), catalysts, raw materials and reagents. ALS Scandinavia offers GMP analysis for: GMP release Quality Control (QC) Stability studies API analysis Analysis of excipients (excipients) Metal catalysts And more WHICH MATERIALS SHOULD BE TESTED? These new guidelines and chapters generally cover finished pharmaceutical products, but it is usually wise to also test individual ingredients such as starting materials, raw materials, APIs and excipients. This is to get a detailed picture of the individual components and at the same time avoid the risk of ending up in an OOS situation for a ready-made pharmaceutical product without knowing where one or more metal impurities ( elemental impurities ) may originate. MENU Currently Analysis Technology- ICP-SFMS Method development and validation Analysis strategy Laboratory Send samples Elemental impurities Analysis package CONTACT US Send RELATED INFORMATION Oxy-PAH Order form metals in medicines GMP certificate Arsenic speciation Additional elements - LOQ In English » AS SCANDINAVIA Your partner for chemical analysis in the environment, food, pharmaceuticals, electronics, human biology and other areas. CUSTOMER SERVICE Order forms Order sample vessels Info sheet Instructions Contact Us THE COMPANY About ALS Recruitment Quality Research Reference information Links OTHER Facebook LinkedIn Mobile site ALS IN THE NORDICS ALS Denmark AS Finland AS Norway ALS Scandinavia AB © 2016