Menu
Get a Quote >
SGS has recognized the need for trace elemental analysis within the pharmaceutical industry. With the changes that are happening in regards to heavy metal methodology to determine elemental impurities in pharmaceutical products, SGS is positioned to serve you efficiently with scientifically sound data to comply with the new methods as they are soon to go into effect.
APIs
Excipients
Finished Products
Raw Ingredients
Extractables/Leachables
USP <232> / ICH Q3D Elemental Impurities
(Class 1): Arsenic, Cadmium, Lead, Mercury
(Class 2A): Cobalt, Molybdenum, Selenium, Vanadium
(Class 2B): Gold, Iridium, Osmium, Palladium, Platinum, Rhodium, Ruthenium, Silver, Thallium
(Class 3): Antimony, Barium, Chromium, Copper, Lithium, Nickel, Tin
USP <232>/<233>
As a replacement to USP <231> Heavy Metals Limits test, these new USP Chapters provide method, procedure and regulatory limit guidance for excipients, APIs, drug substances, and drug products.
USP <1225> Validation of Compendial Procedures
Defines analytical performance characteristics of method (ICP-MS) to specific products. This is accomplished by measuring any combination of the following: Accuracy, Precision, Specificity, Limit of Detection, Limit of Quantitation, Linearity, Range and Ruggedness.
USP <1226> Verification of Compendial Procedures
May be used with limited or selective performance characteristics, identified in USP <1225>. If not successful, then implementation of USP <1225> should be considered.
FDA GMP/GLP
21 CFR Part 210/211 and 58
