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Merck

1445539

USP

USP mAb 001, Monoclonal IgG1

United States Pharmacopeia (USP) Reference Standard

Synonyme(s) :

Monoclonal IgG1

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2 MG

1 270,00 €

1 270,00 €


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A propos de cet article

Numéro CAS:
MDL number:
NACRES:
NA.24
UNSPSC Code:
41116107

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Nom du produit

USP mAb 001, Monoclonal IgG1, United States Pharmacopeia (USP) Reference Standard

form

liquid

mol wt

~147,000 Da

packaging

pkg of 2 mg

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical

format

neat

storage temp.

−70°C

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1 of 4

Cet article
14455471445595SAB4200683
manufacturer/tradename

USP

manufacturer/tradename

USP

manufacturer/tradename

USP

manufacturer/tradename

-

format

neat

format

neat

format

neat

format

-

application(s)

pharmaceutical

application(s)

pharmaceutical

application(s)

pharmaceutical

application(s)

-

mol wt

~147,000 Da

mol wt

~150,000 Da

mol wt

~146,000 Da

mol wt

-

packaging

pkg of 2 mg

packaging

pkg of 2 mg

packaging

pkg of 2 mg

packaging

-

storage temp.

−70°C

storage temp.

−70°C

storage temp.

−70°C

storage temp.

−20°C

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.  

Application

  • Size-Exclusion Chromatography
  • Capillary SDS Electrophoresis (Reduced and Nonreduced)
  • Analysis of N-Linked Oligosaccharides
  • Sialic Acid Analysis
  • Intact Mass
  • Sequence identification by peptide mapping
  • Independent control material for method development, training, and method transfer
  • Internal assay control for standardization of physico-chemical testing

Features and Benefits

  • 4 Unique proteins with unique quality attributes
  • Extensively characterized for confidence in method development
  • Technical Note available

General description

USP mAb 001 is a recombinant human monoclonal IgG1 antibody used as a representative analytical standard. It supports identity testing, aggregation analysis, glycosylation profiling, and system suitability in methods developed for monoclonal antibody characterization and biosimilar comparison.

The USP biologics monoclonal antibodies (mAb) category includes a range of therapeutic proteins that are designed to target specific antigens, providing effective treatments for various diseases, including cancers and autoimmune disorders. Monoclonal antibodies are produced using hybridoma technology and are essential in both diagnostics and therapeutics. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of monoclonal antibody products throughout their lifecycle.

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.

Other Notes

Sales restrictions may apply.
This product is part of the USP Biologics program.
USP has developed four monoclonal antibody Reference Standards (mAb System Suitability, mAb 001, mAb 002, and mAb 003) to provide a range of reference materials with different physico-chemical properties. These products underwent USP′s rigorous collaborative testing process including assessment by the USP General Chapter 129 methods.

Classe de stockage

12 - Non Combustible Liquids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Contenu apparenté

Discover our wide variety of products for intact mass analysis of monoclonal antibodies, including size-exclusion columns (SEC), ion exchange columns, reverse-phase columns, HPLC buffers, MALDI matrices and standards, high-purity solvents, reagents, tools for protein sample preparation, and certified reference materials.

Bestellen Sie aus einer breiten Palette hochgradig charakterisierter Materialien als primäre Referenzstandards zur Verwendung mit USP-NF-Monographien für die Prüfung von Arzneistoffen und Darreichungsformen, pharmazeutischen Hilfsstoffen, Lebensmittelinhaltsstoffen und Nahrungsergänzungsmitteln.

Entdecken Sie unsere große Auswahl an Produkten für die Analyse der intakten Masse monoklonaler Antikörper, darunter Größenausschlusssäulen (SEC), Ionenaustauschsäulen, Umkehrphasensäulen, HPLC-Puffer, MALDI-Matrizen und -Standards, hochreine Lösungsmittel, Reagenzien, Werkzeuge für die Vorbereitung von Proteinproben und zertifizierte Referenzmaterialien.

Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.

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Questions

  1. Hi, What is the volume of this 2mg/mL mAb sample? Thanks

    1 answer
    1. This is a product of the United States Pharmacopeia (USP). The current lot lists a volume of 200 µl. The amount may change from lot to lot.

      Please see the link below to access the current Certificate of Analysis issued by the USP:
      https://static.usp.org/pdf/EN/referenceStandards/certificates/1445539-F11920.pdf

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