Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name CAS No. Quantity
Date of Analysis
Degarelix Acetate Powder (Synthetic) 214766-78-6 200g
Batch No. Specification Mfg. Date
2018.12.29
Expiry Date
20181228 In-house 2018.12.28 2020.12.29
Sequence: Ac-D2Nal-D4Cpa-D3Pal-Ser-4Aph(L-Hor)-D4Aph(Cbm)-Leu-Lys(Ipr)-Pro-DAla-NH2
Test
Specification
Result
Appearance
White or off-white powder
White powder
Solubility
Soluble in water and 1% acetate acid
conforms
The principal peak in the chromatogram
obtained
with the test solution is similar in retention time to
HPLC
principal peak in the chromatogram obtained with the
conforms
reference solution. MS
1632.3Âą1.0
conforms
Related Substances
Unspecified impurity for each impurity: NMT1.0%
0.33%(single largest impurity)
Purity(HPLC)
NLT 98.0%
99.2%
Acetic acid
NMT 3.4~6.8%
4.9%
Water
NMT 7.0%
4.3%
Bacterial endotoxins
Less than 5IU/mg
conforms
97.0%-103.0%
Assay
(anhydrous and acetic acid free subtance)
98.5%
Residual solvent Methanol
NMT 3000ppm
Acetonitrile
NMT 410 ppm
Triethylamine
NMT 320 ppm
conforms
Conclusion: The test product complies with the requirements of specification. Analyst: Dai
Checker: LV
Q.C.Director: ZhangLi