Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name
Pramlintide Acetate Powder (Synthetic)
Batch No.
20181030
CAS No.
196078-30-5
Specification
In-house
Quantity
200g
Mfg. Date
2018.10.30
Date of Analysis
2018.10.31
Expiry Date
2020.10.31
Sequence: Lys-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-Gln-Arg-Leu-Ala-Asn-Phe-Leu-Val-His-Ser-Ser-Asn-Asn-Phe-Gly-Pro-I le-Leu-Pro-Pro-Thr-Asn-Val-Gly-Ser-Asn-Thr-Tyr-NH2(Cys2&Cys7 bridge）
Test
Specification
Result
Appearance
White or off-white powder
White powder
Solubility
Soluble in water
conforms
The principal peak in the chromatogram obtained HPLC
with the test solution is similar in retention time to principal peak in the chromatogram obtained
conforms
with the reference solution. MS
3949.4±1.0
conforms
Purity(HPLC)
NLT 96%
97.68%
Acetic acid
NMT 8.0%
6.2%
Water
NMT 7.0%
4.2%
Assay
97.0%-103.0% (anhydrous and acetic acid free subtance)
98.1%
Conclusion: The test product complies with the requirements of specification. Analyst: Dai
Checker: LV
Q.C.Director: ZhangLi