100% EP Standard Telmisartan Pharmaceutical Raw Materials Treatment Hypertension
Molecular Formula:C33H30N4O2
Formula Weight: 514.63
CAS No.:144701-48-4
Appearance:white powder
Purity:100%
Telmisartan is an angiotensin II receptor antagonist (angiotensin receptor blocker, ARB) used in the management of hypertension.
Medical uses:
Telmisartan is indicated in the treatment of essential hypertension.
Contraindications:
Telmisartan is contraindicated during pregnancy. Like other drugs affecting the renin-angiotensin system (RAS), telmisartan can cause birth defects, stillbirths, and neonatal deaths. It is not known whether the drug passes into the breast milk.[5] Also it is contraindicated in bilateral renal artery stenosis in which it can cause renal failure.
The COA:
|
Product name |
TELMISARTAN |
|
CAS No. |
144701-48-4 |
Outer Packing |
25KG/drum |
|
Production date |
2016-5-30 |
Shelf life |
2018-5-29 |
|
Standard adopted |
EP7.0 |
|
Items of analysis |
Specification |
Results |
|
Appearance |
White or slightly yellowish,crystalline powder |
Conform |
| Solubility |
Insoluble water,slightly soluble in methanol,sparingly soluble in methylene chloride.It dissolves in 1M sodium hydroxide. |
Conform |
| IDENTIFICATION |
|
|
| A |
Infra-red absorption spectrum should be identical with contrast. |
Contorm |
| TESTS |
|
|
|
Appearance of solution |
Dissolve 0.5g in 1M sodium hydroxide and dilute to 10ml with the same solvent:NMT Y4 |
Contorm |
| Related substances |
Impurities C:NMT 0.2% |
Unfound |
| Related substances |
Impurities D:NMT 0.2% |
0.04% |
| Related substances |
Impurities A:NMT 0.15% |
0.005% |
| Related substances |
Impurities B:NMT 0.15% |
0.006% |
| Related substances |
Unspecified impurities:NMT 0.1% |
0.05% |
| Related substances |
Total impurities:NMT 1.0% |
0.27% |
| Loss on drying |
NMT 0.5% |
0.5% |
| Sulphated ash |
NMT 0.1% |
0.05% |
| Residual Solvents |
Methanol:NMT 3000ppm |
Unfound |
|
Residual Solvents |
1,2-dimethoxyethane:NMT 100ppm |
Unfound |
|
Residual Solvents |
Ethanol:NMT 5000ppm |
Unfound |
|
Residual Solvents |
Acetic acid:NMT 5000ppm |
Unfound |
|
ASSAY |
99.0%~101.0% |
100.0% |
|
Conclusion |
Qualified |
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