CAS number: 111470-99-6
Molecular formula:
molecular weight:
Chemical structure:
Sr No. | Test | Specification | Result |
1 | Description | White or almost White powder. | Almost white Powder |
2 | Solubilty | Slightly soluble in water , Freely soluble in methanol, sparingly soluble in alcohol , slightly soluble in 2-propanol | Complies |
3 | Identification | ||
i) IR | i) The infrared absorption spectrum of the substances being examined in mulls should be concordant with the spectrum Obtained form Amlodipine Besilate Working standard | Complies | |
Ii) By HPLC | ii) The retention of major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation as Obtained in the Assay. | Complies | |
4 | Optical Rotation | -0.100 to +0.100 | 0.000 |
5 | Water | Not more than 0.50 % w/w | 0.19% |
6 | Residue on ignition | Not more than 0.20 % w/w | 0.03% |
Related Substances By TLC | Any spot obtained from the test solution Except for the principal spot is not greater than the spot obtained from Standard solution 1 (0.3 %) and at most two spots are more intense than the spot Obtained from standard solution 2(0.1%) | Complies | |
7 | Related Substances By HPLC | ||
Amlodipine Impurity A | Not more than 0.30 % | 0.02% | |
Total of other Impurities | Not more than 0.30 % | 0.18% | |
8 | Assay By HPLC On anhydrous basis | Not less than 97.0 % w/w and Not more than 102.0 % w/w on anhydrous basis | 99.69% |
9 | Microbial test (CFU/g) | ||
a. Aerobic Microorganism | Not more than 1000 cfu/gm | Less than 10 cfu/gm | |
b. Mold & Yeasts | Not more than 100 cfu/gm | Less than 10 cfu/gm | |
Pathogens | |||
i) E.coli | Absent | Absent | |
ii) Salmonella | Absent | Absent | |
iii) S.aureus | Absent | Absent | |
iv) Pesudomonas aeruginosa | Absent | Absent | |
10 | Heavy metals | Not more than 0.002 % | Less than 0.002 % |
11 | Residual Solvents By HSGC | ||
Methanol | Not more than 3000 ppm | 803.66 ppm | |
Ethyl acetate | Not more than 5000 ppm | 374.19 ppm | |
Toluene | Not more than 890 ppm | Not detected |