Przejdź do zawartości
Merck

1445550

USP

Przydatność systemu monoklonalnych IgG

United States Pharmacopeia (USP) Reference Standard

Zaloguj się, aby wyświetlić ceny organizacyjne i kontraktowe.

Wybierz wielkość

2 MG

7470,00 zł

7470,00 zł


Skontaktuj się z Obsługą Klienta, aby uzyskać informacje na temat dostępności

Zamów zamówienie zbiorcze

Informacje o tej pozycji

NACRES:
NA.24
UNSPSC Code:
41116107

Przejdź do

Pomoc techniczna
Potrzebujesz pomocy? Nasz zespół doświadczonych naukowców chętnie Ci pomoże.
Pozwól nam pomóc

grade

pharmaceutical primary standard

form

lyophilized (cake), lyophilized powder

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

Porównaj podobne pozycje

Wyświetl pełne porównanie

Pokaż różnice

1 of 4

Ta pozycja
145784412133291448560
grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

manufacturer/tradename

USP

manufacturer/tradename

USP

manufacturer/tradename

USP

manufacturer/tradename

USP

format

neat

format

neat

format

neat

format

mixture

form

lyophilized (cake)

form

-

form

-

form

-

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

storage temp.

−20°C

storage temp.

-

storage temp.

-

storage temp.

−20°C

General description

This reference standard is used to evaluate the performance of analytical methods for monoclonal antibodies.

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.

Application

This USP reference standard is intended for use in specified quality tests and assays as specified in USP compendia.
It is also used to prepare system suitability solution for the mobile phase as per the chapter 129 “Analytical procedures for recombinant therapeutic monoclonal antibodies” of United States Pharmacopeia (USP) for the measurement of:

  • Low-molecular-weight species (LMWS, fragments) of monoclonal antibodies (mAbs) by size exclusion-high performance liquid chromatography (SE-HPLC)
  • Product-related impurities such as non-glycosylated molecules, half antibodies, and fragments by capillary sodium dodecyl sulfate (CE-SDS) electrophoresis

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 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.
Ta strona może zawierać tekst przetłumaczony maszynowo.

Klasa składowania

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable


Wybierz jedną z najnowszych wersji:

Certyfikaty analizy (CoA)

Lot/Batch Number

It looks like we've run into a problem, but you can still download Certificates of Analysis from our Dokumenty section.

Proszę o kontakt, jeśli potrzebna jest pomoc Obsługa Klienta

Masz już ten produkt?

Dokumenty związane z niedawno zakupionymi produktami zostały zamieszczone w Bibliotece dokumentów.

Odwiedź Bibliotekę dokumentów

Analytical procedures for recombinant therapeutic monoclonal antibodies
United States Pharmacopeia/National Formulary, 39(3), 6565-6565 (2016)

Powiązane treści

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.

Odkryj naszą szeroką gamę produktów do analizy masy przeciwciał monoklonalnych w stanie nienaruszonym, w tym kolumny wykluczające (SEC), kolumny jonowymienne, kolumny fazy odwróconej, bufory HPLC, matryce i wzorce MALDI, rozpuszczalniki o wysokiej czystości, odczynniki, narzędzia do przygotowywania próbek białek i certyfikowane materiały referencyjne.

Numer pozycji handlu globalnego

SKUNUMER GTIN
1445550-2MG04061838735713

Questions

Reviews

No rating value

Active Filters

Nasz zespół naukowców ma doświadczenie we wszystkich obszarach badań, w tym w naukach przyrodniczych, materiałoznawstwie, syntezie chemicznej, chromatografii, analityce i wielu innych dziedzinach.

Skontaktuj się z zespołem ds. pomocy technicznej