Product Brief Introduction
Product name: Telmisartan
CAS：144701-48-4
MF: C33H30N4O2
MW: 514.617
Product Specification
|
Item |
Specification |
|
Appearance |
White or slightly yellowish crystalline powder |
|
Identification |
IR: TR spectrum accords with Telmisartan RS.Characteristic band at 830±2cm' should be not found in the IR spectrum of Telmisartan drug substance. |
|
HPLC: The retention time of the major peak as obtained in the assay test of the sample solution corresponds to that of the standard solution |
|
|
Loss on Drying |
≤ 0.5% |
|
Residue on Ignition |
≤ 0.1% |
|
Related Substances (HPLC) |
Impurity A≤ 0.1% |
|
Impurity B ≤ 0.1% |
|
|
Teimisartan amide ≤ 0.1% |
|
|
Telmisartan diacid ≤ 0.1% |
|
|
Telmisartan tert-butyl ester≤ 0.2% |
|
|
Impurity RRT1.8≤ 0.2% |
|
|
Unspecified impurity ≤ 0.1% |
|
|
Total impurities ≤ 1.0% |
|
|
Residual Solvents (GC) |
Ethanol ≤ 5000ppm |
|
Ethyl acetate ≤ 5000ppm |
|
|
Toluene ≤ 890ppm |
|
|
Acetic acid ≤ 5000ppm |
|
|
Assay (HPLC) (on anhydrous basis) |
98.0%-102.0% |
