Basic Info.
Model NO.:CAS 11470-99-6
Powder:Yes
Customized:Customized
State:Solid
Purity:>99%
Apearance:White or Almost White Powder
Delivery Date:Within 1 Week
Valid Date:2 Years
Product Name:Amlodipine Besilate
CAS:11470-99-6
Trademark:linebon
Package:25kg/Drum/CTN
Specification:100.1%
Origin:China
Product Description
Specification:
Item |
Requirements |
Test Results |
Appearance |
White or almost white powder |
Complies |
Identification |
IR spectrum is in conformance with that of RS The 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% |
Heavy metals |
≤20ppm |
<20ppm |
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. |
Packaging: 25 KG/DRUM/CTN
Storage: Kept in dry, cool, and shaded place with original packaging, avoid moisture, store at room temperature.
Shelf life: 24 Months
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