Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name CAS No. Quantity Date of Analysis
Sermaglutide Powder (Synthetic)
Batch No.
20181212
910463-68-2
Specification
In-house
200g
Mfg. Date
2018.12.12
2018.12.13
Expiry Date
2020.12.13
Sequence:
His-Aib-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys(PEG2-PEG2γ-Glu-17-carboxyheptadecanoyl)-Glu-Phe-Ile-Ala-Trp-Leu-Val-Arg-Gly-Arg-Gly
Test
Specification
Result
Appearance
White powder
conforms
MS
4113.6±1.0
conforms
Solubility
1mg/ml in DMSO or water(PH=8)
conforms
Amino acid analysis
HPLC
His (0.9-1.1); Asp (0.9-1.1) Ala (2.7-3.3); Val (1.8-2.2) Glu (4.5-5.5); Leu (1.8-2.2) Gly (3.6-4.4); Lys (0.9-1.1) Thr (1.8-2.2); Ile (0.9-1.1) Phe (1.8-2.2); Arg (1.8-2.2) Ser (2.7-3.3); Tyr (0.9-1.1) Aib(Det); AEEA(Det) No more than the traces of other amino acids are present. The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the
His 1.1 ; Asp 1.0 Ala 2.9 ; Val 2.0 Glu 4.9 ; Leu 2.1 Gly 4.1 ; Lys 1.0 Thr 2.2 ; Ile 1.0 Phe 1.9 ; Arg 2.0 Ser 2.9 ; Tyr 1.0 Aib(Det);AEEA(Det) Complies
conforms
Purity
chromatogram obtained with the reference solution. NLT 98.0%
99.5%
Acetate content
NML5.0%
0.7%
Water content(KF)
NMT8.0%
5.1%
Peptide content(N%)
NLT80%
92.1%
Conclusion: The test product complies with the requirements of specification. Analyst: Dai Checker: LV Q.C.Director: ZhangLi