1358503

Leuprolide acetate

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): Leuprolide acetate salt, des-Gly¹⁰-[D-Leu⁶]-LH-RH ethylamide, Leuprorelin
• Empirical Formula (Hill Notation): C₅₉H₈₄N₁₆O₁₂ · xC₂H₄O₂
• CAS Number: 74381-53-6
• Molecular Weight: 1209.40 (free base basis)
• NACRES: NA.24
• PubChem Substance ID: 329750244
• UNSPSC Code: 41116107
• MDL number: MFCD00167544

Properties

• grade: pharmaceutical primary standard
• agency: USP
• API family: leuprolide
• form: powder
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C
• SMILES string: 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
• Gene Information: human ... GNRHR(2798)

Description

General description

Find answers to frequently asked questions on USP products in USP FAQs.

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.

Application

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).

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.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk: WGK 2
• flash_point_f: Not applicable
• flash_point_c: Not applicable