Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name CAS No. Quantity Date of Analysis
Exenatide acetate Powder (Synthetic) 141732-76-5 1kg 2018.12.12
Batch No. Specification Mfg. Date Expiry Date
20181211 In-house 2018.12.11 2020.12.12
Sequence: His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile- Glu-TrpLeu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2
Test
Specification
Result
Appearance
White or off-white powder
White powder
Solubility
soluble in water
conforms
The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal HPLC
Amino acid analysis
MS Related Substances
peak in the chromatogram obtained with the reference
conforms
solution. His 0.9-1.1 Lys 1.8-2.2 Gly 4.5-5.5 Met 0.9-1.1 Glu 5.4-6.6 Ala 1.8-2.2 Thr 1.8-2.2 Val 0.9-1.1 Phe 1.8-2.2 Pro 3.6-4.4 Ser 3.5-5.5 Arg 0.9-1.1 Asp 1.8-2.2 Ile 0.9-1.1 Leu 2.7-3.3 No more than the traces of the other amino
His 1.1 Lys 2.0 Gly 4.9 Met 1.0 Glu 5.8 Ala 2.1 Thr 1.9 Val 0.9 Phe 2.0 Pro 4.1 Ser 3.6 Arg 1.0 Asp 1.9 Ile 1.1 Leu 3.1 No more than the traces of the other
acids are present.
amino acids are present.
4186.6Âą1.0
4187.1
Unspecified impurity for each impurity: NMT0.5%
0.09%(single largest impurity)
Purity(HPLC)
NLT 98%
99.8%
Acetic acid
NMT 7.5%
0.9%
Water
NMT 7.0%
4.7%
Assay
97.0%-103.0% (anhydrous and acetic acid free subtance)
98.3%
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