Products Description
| Product Name | Tirzepatide |
| Cas No. | 2023788-19-2 |
| Application | For export and R&D use only |
Specification
|
Tests |
Acceptance Criteria |
Results |
|
|
Appearance |
White or off-white powder |
White powder |
|
|
Solubility |
Can be dissolved to 5mg/ml in pure water |
Conforms |
|
|
Molecular Ion Mass |
4813.53±1 |
Conforms |
|
|
pH |
7.0~9.0(C=5mg/ml) |
7.6 |
|
|
Water Content(K.F) |
NMT 8.0% |
2.7% |
|
|
Purity(HPLC) |
NLT 98.0% |
99.33% |
|
|
Related substances(HPLC) |
The largest individual impurity test NMT 1.0% |
0.14% |
|
|
The total impurities test NMT 2.0% |
0.67% |
||
|
Residual solvent(GC) |
Methylene chloride |
NMT 600ppm |
N.D |
|
Acetonitrile |
NMT 410ppm |
66ppm |
|
|
Methanol |
NMT 3000ppm |
N.D |
|
|
NN-Dimethylformamide |
NMT 880ppm |
N.D |
|
|
Isopropyl ether |
NMT 5000ppm |
N.D |
|
|
Triethylamine |
NMT 320ppm |
N.D |
|
|
Tert-buryl methyl ether |
NMT 5000ppm |
N.D |
|
|
Acid group ions (HPLC) |
TFA |
NMT 0.1% |
N.D |
|
PO4³ |
NMT 0.1% |
N.D |
|
|
CI |
NMT 0.1% |
N.D |
|
|
HAC |
NMT 0.1% |
N.D |
|
|
Bacterial Endotoxins |
NMT10 EU/mg |
Conforms |
|
|
Microbial Limits |
TAMC |
NMT 1000 cfu/g |
Conforms |
|
TYMC |
NMT 100 cfu/g |
Conforms |
|
|
Escherichia Coil presence |
Negative |
Conforms |
|
|
Salmonella |
Negative |
Conforms |
|
|
P.Aeruginosa |
Negative |
Confoms |
|
|
S.Aureus |
Negative |
Conforms |
|
|
High Molecular Protein |
NMT 0.50% |
N.D |
|
|
Sodium ion |
NMT 5.0% |
1.3% |
|
|
Peptide Content (Mass Balance) |
NLT 80.0% |
95.4% |
|
|
Assay(HPLC) |
95.0-105.0%(on anhydrous and salt-free substance basis) |
99.6% |
|
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