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Merck
CN

1477615

USP

Octreotide Non-Cyclic System Suitability Marker

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-S-[(acetylamino)methyl]-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamide

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About This Item

Empirical Formula (Hill Notation):
C52H73N11O11S2
CAS Number:
Molecular Weight:
1092.33
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24
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grade

pharmaceutical primary standard

API family

octreotide

form

powder

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

General description

Octreotide Non-Cyclic System Suitability Marker is a synthetic linear analog of octreotide used as a system suitability control in chromatographic analysis. It verifies method performance by simulating non-cyclic peptide impurities in octreotide formulations.

The USP biologics peptides category encompasses a diverse range of therapeutic peptides that are essential in managing various medical conditions. These peptides, typically consisting of amino acid sequences of 40 residues or less, are critical for the development of high-quality medicines. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of peptide therapeutics 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

Octreotide Non-Cyclic System Suitability Marker 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 Octreotide Acetate

Other Notes

Sales restrictions may apply.
This product is part of the USP Biologics program.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

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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Octreotide Acetate
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 41(4) , 3228-3228 (2020)

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