Category
Buserelin
CAS Number
Buserelin STD-57982-77-1; EP-IMP-A- 1872434-99-5 ;EP-IMP-F- NA ;EP-IMP-G- NA;
Alternate CAS Number
Buserelin STD-68630-75-1(Acetate)
Molecular Formula
Buserelin STD- C60H86N16O13; EP-IMP-A- C60H86N16O13 ;EP-IMP-F- C63H91N17O15 ;EP-IMP-G- C65H93N17O14;
Molecular Weight
Buserelin STD- 1239.42 g/mol; EP-IMP-A- 1239.4 g/mol ;EP-IMP-F- 1326.5;EP-IMP-G- 1336.6 g/mol ;
Synonym

Buserelin- (S)-1-((3S,6S,9S,12S,15R,18S,21S)-3-((1H-imidazol-5-yl)methyl)-6-((1H-indol-3-yl)methyl)-15-(tert-butoxymethyl)-21-(3-((diaminomethylene)amino)propyl)-12-(4-hydroxybenzyl)-9-(hydroxymethyl)-18-isobutyl-1,4,7,10,13,16,19-heptaoxo-1-((S)-5-oxopyrrolidin-2-yl)-2,5,8,11,14,17,20-heptaazadocosan-22-oyl)-N-ethylpyrrolidine-2-carboxamide; 5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-O-(1,1-dimethylethyl)-D-seryl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide ;

Buserelin EP Impurity A - [2-D-histidine]buserelin ; (S)-1-((3R,6S,9S,12S,15R,18S,21S)-3-((1H-imidazol-5-yl)methyl)-6-((1H-indol-3-yl)methyl)-15-(tert-butoxymethyl)-21-(3-guanidinopropyl)-12-(4-hydroxybenzyl)-9-(hydroxymethyl)-18-isobutyl-1,4,7,10,13,16,19-heptaoxo-1-((S)-5-oxopyrrolidin-2-yl)-2,5,8,11,14,17,20-heptaazadocosan-22-oyl)-N-ethylpyrrolidine-2-carboxamide; 5-Oxo-L-prolyl-D-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-O-(1,1-dimethylethyl)-D-seryl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide;

Buserelin EP Impurity F - Endo-3a-serine-buserelin; (S)-1-((3S,6S,9S,12S,15S,18R,21S,24S)-3-((1H-Imidazol-5-yl)methyl)-6-((1H-indol-3-yl)methyl)-18-(tert-butoxymethyl)-24-(3-guanidinopropyl)-15-(4-hydroxybenzyl)-9,12-bis(hydroxymethyl)-21-isobutyl-1,4,7,10,13,16,19,22-octaoxo-1-((S)-5-oxopyrrolidin-2-yl)-2,5,8,11,14,17,20,23-octaazapentacosan-25-oyl)-N-ethylpyrrolidine-2-carboxamide;

Buserelin EP Impurity G - Endo-8a-proline-buserelin ; (S)-1-(((3S,6S,9S,12S,15R,18S,21S)-3-((1H-Imidazol-4-yl)methyl)-6-((1H-indol-3-yl)methyl)-15-(tert-butoxymethyl)-21-(3-guanidinopropyl)-12-(4-hydroxybenzyl)-9-(hydroxymethyl)-18-isobutyl-1,4,7,10,13,16,19-heptaoxo-1-((S)-5-oxopyrrolidin-2-yl)-2,5,8,11,14,17,20-heptaazadocosan-22-oyl)-L-prolyl)-N-ethylpyrrolidine-2-carboxamide;

 

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Buserelin for peak identification CRS is used as a reference standard to confirm the identity of the buserelin peak in chromatographic analysis. It ensures accurate peak assignment and reliable identification in accordance with the relevant pharmacopoeial method.