We Can Assist You In Testing For These Regulations
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.
21 CFR Part 210/211 and 58