Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS 20181208
Product Name
Lanreotide Powder (Synthetic)
Batch No.
CAS No.
108736-35-2
Specification In-house
Quantity
1 kg
Mfg. Date
2018.12.08
Date of Analysis
2018.12.09
Expiry Date
2020.12.09
Sequence: {D-2Nal}-Cys-Tyr-{D-Trp}-Lys-Val-Cys-Thr-NH2(Cys2&Cys7 bridge) Test
Specification
Appearance
White or off-white powder
White powder
Solubility
soluble in water
conforms
MS
1096.3±1.0
Result
conforms
Related Substances
Unspecified impurity for each impurity: NMT1.0%
0.26%(single largest impurity)
Purity(HPLC)
NLT 98%
99.44%
Acetic acid
NMT 13.0%
9.8%
Water Content(Karl Fischer） Peptide Content(N%)
NMT 8.0%
4.3%
NLT80%
85.5%
Conclusion: The test product complies with the requirements of specification. Analyst: Dai
Checker: LV
Q.C.Director: ZhangLi