A dihydropyridine calcium channel blocker. Used as an antianginal and antihypertensive
Packing
Discreet packing ways as your requirement, 100% go through
Storage
Store in cool and dry area and keep away from direct sunlight
Specification:
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Item
Specification
Result
Appearance
White or almost white powder
Complies
Identification
IR spectrum is in conformance with that of RSThe retention time of the 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
Optical rotation
-0.10°~+0.10°
+0°
Water
≤0.5%
0.10%
Residue on ignition
≤0.02%
0.004%
Related substances
TLC method: any impurity ≤0.3%, at most 2 impurities more than 0.1%
Complies
HPLC method: amlodipine impurity A ≤0.3% Total of other impurity ≤0.3%
Impurity A=0.002% Total of other impurity= 0.05%
Residual solvent
Ethanol ≤2000pm (loss on drying)
500ppm
Microbiological test
Total aerobic microbial count: ≤1X10²CFU/g
Total molds and yeast count: 1X10²CFU/g
E.coli: absert(1g)
10CFU/G
10CFU/G
Absent
Assay
97.0%~102.0%
100.1%
Conclusion
The results conforms with USP31
Use:
1.A dihydropyridine calcium channel blocker. Used as an antianginal and antihypertensive.
2.Angiotensin II inhibitor prodrug, antihypertensive.
3.Amlodipine besylate is a L-type calcium channel blocker which may be used for the treatment of angina pectoris and hypertension. Amlodipine also inhibits growth of human epidermoid carcinoma A431 cells and has antireproductive effects in male rats.
Description:
Amlodipine (generic name Amlodipine Besylate) is a class of calcium channel blockers.
Amlodipine functionalizes by the dilation of blood vessels and the improvement of blood flow, which lead to lowered blood pressure. Thereby, it is used to treat high bold pressure (hypertension). Lowering high blood pressure also reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions, and kidney problems. Amlodipine is also used to prevent certain types of chest pains (angina), which may help to increase the ability to exercise and decrease the frequency of angina attacks. Amlodipine can be used to treat coronary artery disease (CAD) including chronic stable angina, vasospastic angina, and angiographically documented CAD.
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