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Merck
CN

1467837

USP

PS NMR System Suitability

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Hyaluronate sodium oligomer, Hyaluronic acid oligosaccharide

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24
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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

PS NM System Suitability reference standard for use in specified quality tests and assays.

Also used to prepare system suitability solutions according to the United States Pharmacopeia (USP) general chapter.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

Other Notes

Sales restrictions may apply.
This product is part of the USP Biologics program.
This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets, have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia

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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Certificates of Analysis (COA)

Lot/Batch Number

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{?198? Nuclear magnetic resonance spectroscopy identity testing of bacterial polysaccharides used in vaccine manufacture}
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 43(2), 6596-6596 (2018)

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