Expert articles from our technical team on analytical testing methods, regulatory requirements, and quality best practices.
A comprehensive guide to bacterial endotoxin testing per USP <85>, including LAL methods, acceptance criteria, and why endotoxin testing is critical for injectable and implantable products.
Compare HPLC and LC-MS analytical techniques — when to use each, their strengths and limitations, and how to select the right method for purity, potency, and identity testing.
Everything supplement manufacturers need to know about FDA 21 CFR Part 111 testing requirements, including identity, purity, strength, composition, and contaminant testing.
Learn what ISO/IEC 17025 accreditation means, how it differs from ISO 9001, and why it should be a key factor when selecting an analytical testing laboratory.
A complete guide to the analytical tests required for peptide quality control — purity by HPLC, identity by LC-MS, endotoxin, sterility, and heavy metals testing.
An introduction to ICH stability testing guidelines, including accelerated and long-term study designs, storage conditions, and how stability data supports shelf life claims.
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