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Merck
CN

1269105

USP

Exenatide

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Exendin-4

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About This Item

Empirical Formula (Hill Notation):
C184H282N50O60S
CAS Number:
141758-74-9
Molecular Weight:
4186.57
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
MFCD00240171

Key Documents

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SMILES string

S(CC[C@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CNC(=O)[C@@H](NC(=O)CNC(=O)[C@@H](N)Cc9nc[nH]c9)CCC(=O)O)[C@H](O)C)Cc8ccccc8)[C@H](O)C)CO)CC(=O)O)CC(C)C)CO)CCCCN)CCC(=O)N

InChI

1S/C184H282N50O60S/c1-16-94(10)147(178(289)213-114(52-58-144(257)258)163(274)218-121(73-101-77-195-105-39-24-23-38-103(101)105)168(279)215-116(68-90(2)3)165(276)205-107(41-26-28-61-186)158(269)219-122(75-134(189)243)154(265)198-79-135(244)196-83-139(248)231-63-30-43-129(231)175(286)225-127(87-238)174(285)223-125(85-236)155(266)200-80-136(245)202-96(12)181(292)233-65-32-45-131(233)183(294)234-66-33-46-132(234)182(293)232-64-31-44-130(232)176(287)222-124(84-235)150(190)261)229-170(281)119(71-99-34-19-17-20-35-99)217-166(277)117(69-91(4)5)214-159(270)108(42-29-62-194-184(191)192)212-177(288)146(93(8)9)228-151(262)95(11)203-156(267)111(49-55-141(251)252)208-161(272)112(50-56-142(253)254)209-162(273)113(51-57-143(255)256)210-164(275)115(59-67-295-15)211-160(271)110(47-53-133(188)242)207-157(268)106(40-25-27-60-185)206-172(283)126(86-237)224-167(278)118(70-92(6)7)216-169(280)123(76-145(259)260)220-173(284)128(88-239)226-180(291)149(98(14)241)230-171(282)120(72-100-36-21-18-22-37-100)221-179(290)148(97(13)240)227-138(247)82-199-153(264)109(48-54-140(249)250)204-137(246)81-197-152(263)104(187)74-102-78-193-89-201-102/h17-24,34-39,77-78,89-98,104,106-132,146-149,195,235-241H,16,25-33,40-76,79-88,185-187H2,1-15H3,(H2,188,242)(H2,189,243)(H2,190,261)(H,193,201)(H,196,244)(H,197,263)(H,198,265)(H,199,264)(H,200,266)(H,202,245)(H,203,267)(H,204,246)(H,205,276)(H,206,283)(H,207,268)(H,208,272)(H,209,273)(H,210,275)(H,211,271)(H,212,288)(H,213,289)(H,214,270)(H,215,279)(H,216,280)(H,217,277)(H,218,274)(H,219,269)(H,220,284)(H,221,290)(H,222,287)(H,223,285)(H,224,278)(H,225,286)(H,226,291)(H,227,247)(H,228,262)(H,229,281)(H,230,282)(H,249,250)(H,251,252)(H,253,254)(H,255,256)(H,257,258)(H,259,260)(H4,191,192,194)/t94-,95-,96-,97+,98+,104-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,127-,128-,129-,130-,131-,132-,146-,147-,148-,149-/m0/s1

InChI key

HTQBXNHDCUEHJF-XWLPCZSASA-N

grade

pharmaceutical primary standard

API family

exenatide

form

solid

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical

format

neat

Related Categories

General description

Exenatide is a 39-amino acid peptide agonist of the glucagon-like peptide-1 (GLP-1) receptor, originally derived from Heloderma suspectum venom. It enhances glucose-dependent insulin secretion and is used in type 2 diabetes management. The USP standard is employed in identity testing, potency assays, and impurity profiling in GLP-1 analog 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

Exenatide 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:
  • Exenatide Injection

Other Notes

Sales restrictions may apply.
This product is intended for use as a reference standard in pharmaceutical research and development. This product is for test and assay use only. It is not tested for animal or human consumption, clinical testing, or therapeutic use.
This product is part of the USP Biologics program.

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

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Exenatide
USP43-NF38: United States Pharmacopeia and National Formular
United States Pharmacopeia, 45(3), 1800-1800 (2017)

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