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Gonadorelin Acetate
medicine and healthy production
34973-08-5
1 Assay(ByAnhydrous,AceticAcid-free) 95.0¢¦102.0% 98.5%
2 Appearance White to Off-white powder Complies
3 Solubility Soluble in water and in a 1% glacial acetic acid Complies
4 Identity (by HPLC) The retention is same with the reference substance Complies
5 Identity (by TLC) The principal spot corresponds in position and size to the reference substance Complies
6 Appearance of Solution 10mg/ml solution is clear and not more intensely colored than reference solution Complies
7 Specific Optical Rotation -54.0¢¦-66.0¡Æ(c=1,1%HAc) -62.8¡Æ
8 Absorbance (by UV) 0.55~0.61 (c=0.1mg/ml H2O, ¥ëmax=278nm 0.57
9 Amino Acid Composition Ser:0.7¢¦1.05 Glu:0.95¢¦1.05 Pro:0.95¢¦1.05 Gly:1.90¢¦2.10 Leu:0.90¢¦1.10 Tyr:0.7~1.05 His:0.95~1.05 Arg:0.95~1.05 Trp: Presnt 0.93 0.98 1.02 2.01 0.95 1.01 0.99 1.00 Present
10 Related Substance (By HPLC) Total Impurities (%)¡Â5.0% Largest Single Impurity (%)¡Â 2.0% 1.5% 0.6%
11 Acetate Content (By HPLC) 4.0~7.5% 4.7%
12 Water Content (Karl Fischer) ¡Â7.0% 2.7%
13 Bacterial Endotoxins ¡Â70IU/mg Complies
USP31/EP6
1 Assay(ByAnhydrous,AceticAcid-free) 95.0¢¦102.0% 98.5%
2 Appearance White to Off-white powder Complies
3 Solubility Soluble in water and in a 1% glacial acetic acid Complies
4 Identity (by HPLC) The retention is same with the reference substance Complies
5 Identity (by TLC) The principal spot corresponds in position and size to the reference substance Complies
6 Appearance of Solution 10mg/ml solution is clear and not more intensely colored than reference solution Complies
7 Specific Optical Rotation -54.0¢¦-66.0¡Æ(c=1,1%HAc) -62.8¡Æ
8 Absorbance (by UV) 0.55~0.61 (c=0.1mg/ml H2O, ¥ëmax=278nm 0.57
9 Amino Acid Composition Ser:0.7¢¦1.05 Glu:0.95¢¦1.05 Pro:0.95¢¦1.05 Gly:1.90¢¦2.10 Leu:0.90¢¦1.10 Tyr:0.7~1.05 His:0.95~1.05 Arg:0.95~1.05 Trp: Presnt 0.93 0.98 1.02 2.01 0.95 1.01 0.99 1.00 Present
10 Related Substance (By HPLC) Total Impurities (%)¡Â5.0% Largest Single Impurity (%)¡Â 2.0% 1.5% 0.6%
11 Acetate Content (By HPLC) 4.0~7.5% 4.7%
12 Water Content (Karl Fischer) ¡Â7.0% 2.7%
13 Bacterial Endotoxins ¡Â70IU/mg Complies


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Industrial field pharmaceutical
hangzhou onicon chemical co LTD.
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