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Triptorelin Acetate
pharmaceutical
57773-63-4
Molecular Formula C64H82N18O13
Molecular Weight 1311.46
1 Appearance White or slightly yellowish powder White powder
2 Solubility Soluble in water or 1% acetic acid at a concentration of 1mg/ml to give a clear, colorless solution Conforms
3 Identity by HPLC The retention is same with the reference substance Conforms
4 Specific Optical Rotation -65.0- -75.0¡Æ(c=0.5, 95%HAc) -71.3¡Æ
5 Amino Acid Composition ¡¾10% of theoretical Conforms
6 Peptide Purity (By HPLC) ¡Ã 98.0% by area integration 98.8%
7 Related Substance (By HPLC) Total Impurities(%) ¡Â 2.0% Largest Single Impurity (%) ¡Â 1.0% 1.2% 0.7%
8 Acetate Content ¡Â 15.0% 13.8%
9 Water Content (Karl Fischer) ¡Â 5.0% 1.5%
10 Peptide Content ¡Ã 80.0% 85.3%
11 Bacterial Endotoxins ¡Â5EU/mg Conforms
USP31/EP6
Molecular Formula C64H82N18O13
Molecular Weight 1311.46
1 Appearance White or slightly yellowish powder White powder
2 Solubility Soluble in water or 1% acetic acid at a concentration of 1mg/ml to give a clear, colorless solution Conforms
3 Identity by HPLC The retention is same with the reference substance Conforms
4 Specific Optical Rotation -65.0- -75.0¡Æ(c=0.5, 95%HAc) -71.3¡Æ
5 Amino Acid Composition ¡¾10% of theoretical Conforms
6 Peptide Purity (By HPLC) ¡Ã 98.0% by area integration 98.8%
7 Related Substance (By HPLC) Total Impurities(%) ¡Â 2.0% Largest Single Impurity (%) ¡Â 1.0% 1.2% 0.7%
8 Acetate Content ¡Â 15.0% 13.8%
9 Water Content (Karl Fischer) ¡Â 5.0% 1.5%
10 Peptide Content ¡Ã 80.0% 85.3%
11 Bacterial Endotoxins ¡Â5EU/mg Conforms
Industrial field pharmaceutical
hangzhou onicon chemical co.,ltd
Phone 86-717-6307507
Fax 86-717-6307582
Homepage www.pharma-chemical.com
E-mail cjw9999@163.com
Address Bldg 19 Wenshayayuan/ jiangshan fenghua , No.198 Yanjiangdadao,Yichang City 443003 , Hubei province , China
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