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Merck
CN

1296803

USP

Gonadorelin hydrochloride

United States Pharmacopeia (USP) Reference Standard

别名:

Gonadorelin dihydrochloride

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关于此项目

经验公式(希尔记法):
C55H75N17O13 · 2HCl
化学文摘社编号:
分子量:
1255.21
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24
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SMILES string

[nH]1cnc(c1)C[C@H](NC(=O)[C@H]6NC(=O)CC6)C(=O)N[C@@H](Cc4c5c([nH]c4)cccc5)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3ccc(cc3)O)C(=O)NCC(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N2[C@@H](CCC2)C(=O)NCC(=O)N

InChI

1S/C55H75N17O13/c1-29(2)19-38(49(80)67-37(9-5-17-60-55(57)58)54(85)72-18-6-10-43(72)53(84)62-25-44(56)75)66-46(77)26-63-47(78)39(20-30-11-13-33(74)14-12-30)68-52(83)42(27-73)71-50(81)40(21-31-23-61-35-8-4-3-7-34(31)35)69-51(82)41(22-32-24-59-28-64-32)70-48(79)36-15-16-45(76)65-36/h3-4,7-8,11-14,23-24,28-29,36-43,61,73-74H,5-6,9-10,15-22,25-27H2,1-2H3,(H2,56,75)(H,59,64)(H,62,84)(H,63,78)(H,65,76)(H,66,77)(H,67,80)(H,68,83)(H,69,82)(H,70,79)(H,71,81)(H4,57,58,60)/t36-,37-,38-,39-,40-,41-,42-,43-/m0/s1

InChI key

XLXSAKCOAKORKW-AQJXLSMYSA-N

grade

pharmaceutical primary standard

API family

gonadorelin

form

powder

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

General description

Gonadorelin hydrochloride is a synthetic form of gonadotropin-releasing hormone (GnRH), used diagnostically and therapeutically to assess pituitary function. The USP standard supports identity, potency, and purity testing in gonadorelin drug substances.

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

Gonadorelin hydrochloride USP reference standard intended for use in specified quality tests and assays.

Also used to prepare standard, system suitability, and standard stock solution during the assay, and impurity analysis of Gonadorelin Hydrochloride and Gonadorelin for 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

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. Gonadorelin Hydrochloride is a synthetic polypeptide hygroscopic hormone that possesses the ability to trigger the secretion of luteinizing hormone from the hypothalamus.

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

pictograms

Health hazard

signalword

Warning

Hazard Classifications

Repr. 2 - STOT RE 2

target_organs

Endocrine system

法规信息

涉药品监管产品
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历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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Gonadorelin for Injection
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 40(5), 2143-2143 (2018)
Gonadorelin Hydrochloride
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 40(4), 2146-2146 (2018)

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