1467837
USP
PS NMR System Suitability
United States Pharmacopeia (USP) Reference Standard
Synonym(s):
Hyaluronate sodium oligomer, Hyaluronic acid oligosaccharide
form
solid
packaging
pkg of 168 mg
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecule)
format
neat
storage temp.
−20°C
General description
The PS NMR System Suitability is a critical analytical reference material that supports the identity and quantitation of polysaccharides used in vaccine manufacture. This system is designed to ensure the performance and reliability of Nuclear Magnetic Resonance (NMR) spectroscopy methods, which are pivotal in assessing the quality attributes of polysaccharide components. By providing a benchmark for analytical testing, the PS NMR System Suitability enhances the consistency and accuracy of vaccine formulations, ultimately contributing to the safety and efficacy of the final product.
The USP biologics vaccine standards category encompasses a variety of reference materials and procedures essential for the development, manufacturing, and quality control of vaccines. These standards are critical for ensuring that vaccines meet the necessary safety, efficacy, and quality requirements throughout their lifecycle. The USP provides comprehensive guidelines and reference materials to support manufacturers in producing high-quality vaccines that protect public health.
The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.
Application
Also used to prepare system suitability solutions according to the United States Pharmacopeia (USP) general chapter.
Analysis Note
Other Notes
Storage Class Code
13 - Non Combustible Solids
WGK
WGK 3
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Regulatory Information
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