Leuprorelin EP Impurity A
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62621-13-0Leuprorelin EP Impurity A

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Catalogue No.:VE0024170
CAS No.:62621-13-0
Mol. Formula:C59H84N16O12
Mol. Weight:1209.42 g/mol

Additional information on CAS 62621-13-0

Parent drug

Leuprorelin

IUPAC Name

[4-D-serine]leuprorelin

Pharmacopoeial Synonyms

[D-Ser]-Leuprolide

Other Synonyms

N/A

Smiles

O=C([C@H]1N(C([C@H](CCCNC(N)=N)N(C([C@H](CC2)NC2=O)=O)C([C@H](CC(C)C)NC([C@@H](CC(C)C)NC([C@H](CC3=CC=C(C=C3)O)NC([C@@H](CO)NC([C@H](CC4=CNC5=CC=CC=C45)NC([C@H](CC6=CNC=N6)N)=O)=O)=O)=O)=O)=O)=O)CCC1)NCC

InChI

InChI=1S/C59H84N16O12/c1-6-64-55(84)47-14-10-22-74(47)58(87)48(13-9-21-65-59(61)62)75(56(85)41-19-20-49(78)68-41)57(86)45(24-33(4)5)72-51(80)42(23-32(2)3)70-52(81)43(25-34-15-17-37(77)18-16-34)71-54(83)46(30-76)73-53(82)44(26-35-28-66-40-12-8-7-11-38(35)40)69-50(79)39(60)27-36-29-63-31-67-36/h7-8, 11-12, 15-18, 28-29, 31-33, 39, 41-48, 66, 76-77H, 6, 9-10, 13-14, 19-27, 30, 60H2, 1-5H3, (H, 63, 67)(H, 64, 84)(H, 68, 78)(H, 69, 79)(H, 70, 81)(H, 71, 83)(H, 72, 80)(H, 73, 82)(H4, 61, 62, 65)/t39-, 41-, 42+, 43-, 44-, 45-, 46+, 47-, 48-/m0/s1

Description

The Leuprorelin EP Impurity A standard is a well-characterized compound that aligns with key regulatory guidelines | including USP | EMA | JP | and BP. It plays a crucial role in analytical method development | method validation (AMV) | and quality control (QC) processes | particularly in the manufacturing of Leuprorelin. This impurity standard is valuable for both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) | ensuring reliable and precise analytical outcomes.

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