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USP

Insulin lispro

Name: Insulin lispro
Brand: USP

United States Pharmacopeia (USP) Reference Standard

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About This Item

Empirical Formula (Hill Notation):

C₂₅₇H₃₈₃N₆₅O₇₇S₆

CAS Number:

133107-64-9

Molecular Weight:

5807.57

MDL number:

MFCD01773207

UNSPSC Code:

41116107

NACRES:

NA.24

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Properties

grade

pharmaceutical primary standard

API family

insulin

form

crystalline powder

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

InChI key

WNRQPCUGRUFHED-DETKDSODSA-N

Description

General description

Insulin Lispro is a fast-acting insulin analog created through recombinant DNA methods. It features a reversed sequence of lysine and proline at positions B28 and B29, resulting in rapid onset of action. This insulin analog is employed to manage blood glucose levels around meal times.

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.

Application

Insulin lispro USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:

Insulin Lispro Injection

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

Technical Article available

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.

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Storage Class

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

监管及禁止进口产品

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Insulin Lispro Injection

United States Pharmacopeia and National Formulary

United States Pharmacopeia, 44(4), 2355-2355 (2019)

Insulin Assays