Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name CAS No. Quantity
Date of Analysis
Oxytocin Acetate Powder (Synthetic)
Batch No.
50-56-6
Specification
2kg
Mfg. Date
2018.09.16
Expiry Date
20180915 In-house 2018.09.15 2020.09.16
Sequence: Cys-Tyr-Ile-Gln-Asn-Cys-Pro-Leu-Gly-NH2(Cys1&Cys6 bridge)
Test Appearance
Specification White
Result
or almost white , hygroscopic
powder
conforms
Very soluble in water. It dissolves in dilute Solubility
solutions of acetic acid and of ethanol (96
conforms
per cent). The principal peak in the chromatogram obtained with the test solution is similar in HPLC
retention time to principal peak in the conforms chromatogram obtained with the reference solution.
Amino acid analysis
pH Related Substances
Asp
0.90-1.10
Asp
0.95
Glu
0.90-1.10
Glu
0.98
Pro
0.90-1.10
Pro
1.02
Gly
0.90-1.10
Gly
1.03
Leu
0.90-1.10
Leu
0.97
Ile
0.90-1.10
Ile
1.01
Tyr
0.7-1.05
Tyr
0.85
Half-Cys
1.40-2.10
Half-Cys
1.55
No more than the traces of the other amino
No more than the traces of the other
acids are present.
amino acids are present.
3.0-6.0 (200mg OT in 10ml Of water) Unspecified impurity for each impurity: NMT1.0%
CO2 free
5.1 0.39%(single largest impurity)
Purity(HPLC)
NLT 98%
98.6%
MS
1007.2Âą1.0
conforms
Acetic acid
6.0~10.0%
6.2%
Test
Specification
Result
Water Content(Karl Fischer） NMT 5.0%
4.3%
Assay(By HPLC)
93.0~102.0%
100.2%
Bacterial endotoxins
<300 IU/mg
Conform
Bacterial count
≤100CFU/g
Conform
Biological activity （ calculated on the basis of 1mg of Oxytocin peptide being equivalent to 600IU of biological activity）
With reference to anhydrous and acet
529IU/mg
ic acid free substance As is reference
538IU/mg
Conclusion: The test product complies with the requirements of specification. Analyst: Dai
Checker: LV
Q.C.Director: ZhangLi