Collaboration has been key to the pharmacopeia's achievement. How can you tell what something is? For pharmaceuticals, the question is neither philosophical nor speculative, but practical and could ...

The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program. The ...

Rockville, Md., June 1, 2009 — As the number of food and beverage products sweetened with stevia-based ingredients continues to grow in the United States and worldwide, the U.S. Pharmacopeial (USP) ...

The US Pharmacopeia (USP) has recognized mass photometry as a key orthogonal method for characterizing its new adeno-associated virus (AAV) reference standards, as referenced in the draft general ...

Gene therapy represents one of the fastest growing biotherapeutics worldwide, with AAV at the forefront. This rapid growth is constantly challenging CMC approaches, from manufacturing through release ...

Bio-Techne Corp. TECH has recently entered into a distribution agreement with the U.S. Pharmacopeia (“USP”) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference ...

Usage: Reference standards serve as quality control benchmarks for equipment calibration and verification of measurement methods and analytical accuracy. Characteristics: Chemicals with established ...