100% EP Standard Telmisartan Pharmaceutical Raw Materials Treatment Hypertension
Molekularformel:C33H30N4O2
Formula Weight: 514.63
CAS-Nr.:144701-48-4
Aussehen:weißes Puder
Reinheit:100%
Telmisartan is an angiotensin II receptor antagonist (angiotensin receptor blocker, ARB) used in the management of hypertension.
Medizinische Anwendungen:
Telmisartan is indicated in the treatment of essential hypertension.
Kontraindikationen:
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:
|
Produktname |
TELMISARTAN |
|
CAS-Nr. |
144701-48-4 |
Äußere Verpackung |
25KG/drum |
|
Produktionsdatum |
2016-5-30 |
Haltbarkeit |
2018-5-29 |
|
Norm übernommen |
EP7.0 |
|
Elemente der Analyse |
Spezifikation |
Ergebnisse |
|
Aussehen |
White or slightly yellowish,kristallines Pulver |
Testgegenstände |
| Löslichkeit |
Insoluble water,slightly soluble in methanol,sparingly soluble in methylene chloride.It dissolves in 1M sodium hydroxide. |
Testgegenstände |
| IDENTIFICATION |
|
|
| EIN |
Infra-red absorption spectrum should be identical with contrast. |
Contorm |
| TESTS |
|
|
|
Aussehen der Lösung |
Dissolve 0.5g in 1M sodium hydroxide and dilute to 10ml with the same solvent:NMT Y4 |
Contorm |
| Verwandte Substanzen |
Impurities C:NMT 0.2% |
Unfound |
| Verwandte Substanzen |
Impurities D:NMT 0.2% |
0.04% |
| Verwandte Substanzen |
Verunreinigungen A:NMT 0.15% |
0.005% |
| Verwandte Substanzen |
Impurities B:NMT 0.15% |
0.006% |
| Verwandte Substanzen |
Nicht näher bezeichnete Verunreinigungen:NMT 0.1% |
0.05% |
| Verwandte Substanzen |
Total impurities:NMT 1.0% |
0.27% |
| Trocknungsverlust |
NMT 0.5% |
0.5% |
| Sulfatasche |
NMT 0.1% |
0.05% |
| Restlösemittel |
Methanol:NMT 3000 ppm |
Unfound |
|
Restlösemittel |
1,2-dimethoxyethane:NMT 100ppm |
Unfound |
|
Restlösemittel |
Äthanol:NMT 5000ppm |
Unfound |
|
Restlösemittel |
Acetic acid:NMT 5000ppm |
Unfound |
|
ASSAY |
99.0%~101,0 % |
100.0% |
|
Fazit |
Qualifiziert |
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