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Insulin glargine

United States Pharmacopeia (USP) Reference Standard

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About This Item

CAS Number:
UNSPSC Code:
41116107
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

insulin

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

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General description

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.

Insulin Glargine, a peptide produced by recombinant DNA techniques is composed of two chains - the A-chain (21 amino acids) and the B-chain (32 amino acids), making up a total of 53 amino acids. Its primary structure is almost identical to that of Human Insulin, except for the A21 position, where it has Gly instead of Asn. It has two additional amino acids, Arg (B31) and Arg (B32), located at the end of the B-chain.

Application

Insulin glargine USP reference standard suitable for use in specified USP compendial tests and assays.

Also used to prepare standard, standard stock and system suitability solutions for assay by liquid chromatography in conjunction with a UV detector according to the given below monographs of United States Pharmacopeia (USP):
  • Insulin Glargine Injection
  • Insulin Glargine
  • 〈121〉 Insulin Assays

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.
Sales restrictions may apply.

Storage Class Code

11 - Combustible Solids

WGK

nwg

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Insulin Assays
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 43(4) (2020)
Insulin Glargine Injection
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 46(5) (2022)
Insulin Glargine
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 46(5) (2022)

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