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Merck
CN

1358503

USP

Leuprolide acetate

United States Pharmacopeia (USP) Reference Standard

别名:

Leuprolide acetate salt, des-Gly10-[D-Leu6]-LH-RH ethylamide, Leuprorelin

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关于此项目

经验公式(希尔记法):
C59H84N16O12 · xC2H4O2
化学文摘社编号:
分子量:
1209.40 (free base basis)
MDL编号:
UNSPSC代码:
41116107
PubChem化学物质编号:
NACRES:
NA.24
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等级

pharmaceutical primary standard

API类

leuprolide

表单

powder

制造商/商品名称

USP

应用

USP Biologics
pharmaceutical (small molecule)

包装形式

neat

储存温度

−20°C

SMILES字符串

CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CO)NC(=O)[C@H](Cc3c[nH]c4ccccc34)NC(=O)[C@H](Cc5c[nH]cn5)NC(=O)[C@@H]6CCC(=O)N6

InChI

1S/C59H84N16O12/c1-6-63-57(86)48-14-10-22-75(48)58(87)41(13-9-21-64-59(60)61)68-51(80)42(23-32(2)3)69-52(81)43(24-33(4)5)70-53(82)44(25-34-15-17-37(77)18-16-34)71-56(85)47(30-76)74-54(83)45(26-35-28-65-39-12-8-7-11-38(35)39)72-55(84)46(27-36-29-62-31-66-36)73-50(79)40-19-20-49(78)67-40/h7-8,11-12,15-18,28-29,31-33,40-48,65,76-77H,6,9-10,13-14,19-27,30H2,1-5H3,(H,62,66)(H,63,86)(H,67,78)(H,68,80)(H,69,81)(H,70,82)(H,71,85)(H,72,84)(H,73,79)(H,74,83)(H4,60,61,64)/t40-,41-,42-,43+,44-,45-,46-,47-,48-/m0/s1

InChI key

GFIJNRVAKGFPGQ-LIJARHBVSA-N

基因信息

human ... GNRHR(2798)

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Amino Acid Sequence

Glp-His-Trp-Ser-Tyr-Leu-Leu-Arg-Pro-NHEt

一般描述

Leuprolide acetate is a synthetic nonapeptide agonist of gonadotropin-releasing hormone (GnRH), used in the treatment of hormone-responsive cancers and reproductive disorders. It functions by downregulating pituitary gonadotropin secretion. The USP standard supports identity, potency, and impurity testing in peptide 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.

应用

Leuprolide Acetate USP reference standard is used to prepare standard solutions for the identification, assay, and determination of the purity of leuprolide acetate. Further information is available in monograph, Leuprolide Acetate, USP43-NF38 – 2572 of United States Pharmacopeia (USP).

分析说明

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.  ​

其他说明

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

储存分类代码

11 - Combustible Solids

WGK

WGK 2

闪点(°F)

Not applicable

闪点(°C)

Not applicable

法规信息

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分析证书(COA)

Lot/Batch Number

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Leuprolide Acetate
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 42(2), 2572-2572 (2018)

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