Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name
CAS No. Quantity Date of Analysis
Triptorelin Acetate Powder (Synthetic) 140194-24-7
Batch No.
Specification
1kg
Mfg. Date
2018.12.12
Expiry Date
20181211
In-house 2018.12.11 2020.12.12
Sequence: Pyr-His-Trp-Ser-Tyr-DTrp-Leu-Arg-Pro-Gly-NH2
Test Items
Specification
Test Results
Appearance
White or off-white powder
White powder
Solubility
Sparingly soluble in MeOH, soluble in water and 1% acetate acid
conforms
The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the HPLC
Amino acid analysis
chromatogram obtained with the reference solution. Arg
0.9-1.1
Gly
0.9-1.1
His
0.9-1.1
Leu
0.9-1.1
Pro
0.8-1.0
Tyr
0.9-1.1
Glu
0.9-1.1
Ser
0.7-1.0
No more than the traces of the other amino acids are present. MS
Related Substances Purity(HPLC)
1311.5Âą1.0 Unspecified impurity
conforms
Arg
1.0
Gly
0.9
His
0.9
Leu
0.9
Pro
1.0
Tyr
1.0
Glu
1.0
Ser
0.8
conforms conforms
for each impurity: NMT1.0%
0.45%(single largest impurity)
NLT 98%
99.47%
Acetic acid
NMT 12.0%
7.0%
Water Content(Karl Fischer
NMT 7.0%
4.1%
Bacterial endotoxins
Less than 70IU/mg 97.0%-103.0%
Assay
(anhydrous and acetic acid free subtance)
Residual solvent Methanol
NMT 3000ppm NMT 410 ppm NMT 320 ppm
conforms
98.7 %
conforms
Acetonitrile Triethylamine
Conclusion: The test product complies with the requirements of specification. Analyst: Dai
Checker: LV
Q.C.Director: ZhangLi