Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name CAS No. Quantity Date of Analysis
Octreotide Acetate Powder (Synthetic)
Batch No. Specification
83150-76-9
Mfg. Date
1kg 2018.12.11
Expiry Date
20181210 In-house 2018.12.10 2020.12.11
Sequence: DPhe-Cys-Phe-DTrp-Lys-Thr-Cys-Thr-ol(Cys2&Cys7 bridge)
Test
Specification
Result
Appearance
White or off-white powder
White powder
Solubility
Very soluble in water and Conforms
acetic acid The principal peak in the chromatogram obtained with the test solution is similar HPLC
in retention time to principal peak in the Conforms chromatogram obtained with the reference solution.
Amino acid analysis
Phe
1.8-2.2
Phe
1.9
Thr
0.8-1.2
Thr
0.9
Lys
0.9-1.1
Lys
1.0
Cys
1.7-2.3
Cys
1.8
Thr-ol
Present
Thr-ol
Present
No more than the traces of the other amino No more than the traces of the other MS Related Substances
acids are present.
amino acids are present.
1019.2Âą1.0
Conforms
Unspecified impurity for each impurity: NMT1.0%
0.48%(single largest impurity)
Purity(HPLC)
NLT :98%
99.51%
pH
5.0-7.0
5.4
Acetic acid
5.0~ 12.0%
10.2%
Water Content(Karl Fischer
NMT 7.0%
4.4%
Assay
97.0%-103.0% (anhydrous and acetic acid free subtance)
98.9%
Conclusion: The test product complies with the requirements of specification. Analyst: Dai Checker: LV Q.C.Director: ZhangLi