Documentary standards such as monographs, general chapters, and reference standards are essential for efficiently meeting regulatory requirements and ensuring the intended efficacy and safety of drugs ...
· By creating clear compendial pathways for digital standards and methods, USP hopes to reduce uncertainty and help manufacturers adopt emerging technologies with greater confidence. · Enhanced ...
Effective risk assessments for elemental impurities begin with systematic shortlisting of raw materials based on their likelihood to contribute trace metals or elemental contaminants into drug ...
Standardizing on Ph. Eur. methods generally ensures compliance with USP–NF and JP requirements, applying the tightest acceptance criteria for multi-compendial compliance. Differences in compendial ...
Compendial methods rely on Nuclear Magnetic Resonance (NMR) to meet this need. This whitepaper demonstrates how the USP-NF and Ph. Eur. NMR assay procedures for HP-β-CD and SB-β-CD can be effectively ...
Introduction: Sterility testing of clinical trial radiopharmaceuticals is critical to meeting Good Manufacturing Practices (GMPs) requirements. Testing of long-lived radiopharmaceuticals in accordance ...
Functional classification of excipients for tablets and other pharmaceutical products differs for diverse purposes in pharmaceutical preparation and hence may require different material attributes to ...
ABSTRACT: A novel, simple, and sensitive Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantification of process-related impurities and degradants, as well ...
The process of method modernization, which involves integrating advancements in system and column technology for routine analysis, is a challenge many regulated laboratories face due to a larger focus ...
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