1270457

High Molecular Weight Filgrastim

United States Pharmacopeia (USP) Reference Standard

• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• API family: filgrastim
• form: powder
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C

Description

General description

High Molecular Weight Filgrastim is an aggregate form of the recombinant human granulocyte colony-stimulating factor (rhG-CSF). It is used as a reference standard to assess aggregation and high molecular weight species in biosimilar development and stability testing of filgrastim products.

The USP biologics proteins category provides critical standards and reference materials necessary for the development and manufacturing of therapeutic proteins. These proteins, which can be naturally derived or genetically engineered, are essential in treating various diseases and conditions, ensuring that they meet quality, safety, and efficacy standards.

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.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS 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.

Application

High Molecular Weight Filgrastim USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia.

Also, for use with USP monograph such as Filgrastim

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

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 MSDS 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.

Sales restrictions may apply.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 2
• flash_point_f: 199.9 °F
• flash_point_c: 93.30 °C