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Key Documents

1358503

USP

Leuprolide acetate

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C59H84N16O12 · xC2H4O2
CAS Number:
Molecular Weight:
1209.40 (free base basis)
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

leuprolide

manufacturer/tradename

USP

application(s)

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)

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Amino Acid Sequence

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

General description

Leuprolide Acetate is a synthetic nonapeptide agonist analog of the luteinizing hormone-releasing factor. It contains not less than 97.0% and not more than 103.0 % of leuprolide, calculated on an anhydrous, acetic acid-free basis. Leuprolide Acetate USP Reference Standard 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.

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

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

related product

Storage Class

11 - Combustible Solids

wgk_germany

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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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