100% EP Standard Telmisartan Pharmaceutical Raw Materials Treatment Hypertension
Formule moléculaire:C33H30N4O2
Formule de poid: 514.63
N ° CAS.:144701-48-4
Apparence:poudre blanche
Pureté: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.
Contre-indications:
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:
|
Nom du produit |
TELMISARTAN |
|
n ° CAS. |
144701-48-4 |
Emballage extérieur |
25KG/drum |
|
Date de production |
2016-5-30 |
Durée de conservation |
2018-5-29 |
|
Norme adoptée |
EP7.0 |
|
Éléments d'analyse |
spécification |
Résultats |
|
Apparence |
White or slightly yellowish,poudre cristalline |
Se conformer |
| Solubilité |
Insoluble water,slightly soluble in methanol,sparingly soluble in methylene chloride.It dissolves in 1M sodium hydroxide. |
Se conformer |
| IDENTIFICATION |
|
|
| UN |
Infra-red absorption spectrum should be identical with contrast. |
Contorm |
| TESTS |
|
|
|
apparence de la solution |
Dissolve 0.5g in 1M sodium hydroxide and dilute to 10ml with the same solvent:NMT Y4 |
Contorm |
| Substances apparentées |
Impurities C:NMT 0.2% |
Unfound |
| Substances apparentées |
Impurities D:NMT 0.2% |
0.04% |
| Substances apparentées |
Impurities A:NMT 0.15% |
0.005% |
| Substances apparentées |
Impurities B:NMT 0.15% |
0.006% |
| Substances apparentées |
Unspecified impurities:NMT 0.1% |
0.05% |
| Substances apparentées |
Impuretés totales:NMT 1.0% |
0.27% |
| Perte au séchage |
NMT 0.5% |
0.5% |
| Cendres sulfatées |
NMT 0.1% |
0.05% |
| Residual Solvents |
Methanol:NMT 3000ppm |
Unfound |
|
Residual Solvents |
1,2-dimethoxyethane:NMT 100ppm |
Unfound |
|
Residual Solvents |
Éthanol:NMT 5000ppm |
Unfound |
|
Residual Solvents |
Acetic acid:NMT 5000ppm |
Unfound |
|
ASSAY |
99.0%~101.0% |
100.0% |
|
Conclusion |
Qualifié |
Directeur commercial