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Leuprorelin Acetate
medicine and healthy production
53714-56-0
1 Appearance White powder Conforms
2 Solubility Souble in water or 1% acetic acid at a concentration of¡Ã1mg/ml to give a clear, colorless solution Conforms
3 Identity Monoisotopic Mass: 1209.43¡¾1.0 1209.8
4 Specific optical rotation -38.0¢¦-42.0¡Æ [¥á]20D(c=1,1%HAc) -40.0¡Æ
5 Amino acid Composition Ser: present Glu: 0.85¢¦1.1 Pro: 0.85¢¦1.1 Leu: 0.85¢¦1.1 Tyr: 0.85¢¦1.1 His: 0.85¢¦1.1 Arg: 0.85¢¦1.1 Trp: present 0.88 0.91 1.01 2.06 1.00 0.98 0.95 present
6 Peptide Purity(By HPLC) ¡Ã98.0% by area integration 99.3%
7 RelatedSubstance(BYHPLC) Total Impurities(%)¡Â2.0% Largest Single Impurity(%)¡Â0.5% 0.7% 0.4%
8 Acetate Content 4.7%~9.0% 8.8%
9 Water Content(Karl Fischer) ¡Â5.0% 2.0%
10 Bacterial Endotoxins ¡Â16.7IU/mg Conforms
11 Peptide Content ¡Ã80.0% 90.2%
12 Assay(By Anhydrous,Acetic Acid-free) 97.0¢¦103.0% 100.5%
USP31/EP6
1 Appearance White powder Conforms
2 Solubility Souble in water or 1% acetic acid at a concentration of¡Ã1mg/ml to give a clear, colorless solution Conforms
3 Identity Monoisotopic Mass: 1209.43¡¾1.0 1209.8
4 Specific optical rotation -38.0¢¦-42.0¡Æ [¥á]20D(c=1,1%HAc) -40.0¡Æ
5 Amino acid Composition Ser: present Glu: 0.85¢¦1.1 Pro: 0.85¢¦1.1 Leu: 0.85¢¦1.1 Tyr: 0.85¢¦1.1 His: 0.85¢¦1.1 Arg: 0.85¢¦1.1 Trp: present 0.88 0.91 1.01 2.06 1.00 0.98 0.95 present
6 Peptide Purity(By HPLC) ¡Ã98.0% by area integration 99.3%
7 RelatedSubstance(BYHPLC) Total Impurities(%)¡Â2.0% Largest Single Impurity(%)¡Â0.5% 0.7% 0.4%
8 Acetate Content 4.7%~9.0% 8.8%
9 Water Content(Karl Fischer) ¡Â5.0% 2.0%
10 Bacterial Endotoxins ¡Â16.7IU/mg Conforms
11 Peptide Content ¡Ã80.0% 90.2%
12 Assay(By Anhydrous,Acetic Acid-free) 97.0¢¦103.0% 100.5%

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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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