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Nebivolol is a β1 receptor blocker with nitric oxide-potentiating vasodilatory effect used in treatment of hypertension and, in Europe, also for left ventricular failure. It is highly cardioselective under certain circumstances.
Specification:
|
TEST |
SPECIFICATION |
|
DESCRIPTION |
A WHITE CRYSTALLINE POWDER |
|
IDENTIFICATION 1.HPLC 2.UV 3.IR 4.FLUORIDE |
MEETS THE REQUIREMENTS MEETS THE REQUIREMENTS MEETS THE REQUIREMENTS MEETS THE REQUIREMENTS |
|
ASSAY |
98%-102% (CALCULATED ON ANHYDROUS BASIS) |
|
PH |
4.5-6.5 |
|
RELATED SUBSTANCE |
≤1.0% |
|
STEREOISOMER |
≤0.5% |
|
LOSS ON DRYING |
≤0.5% |
|
HEAVY METALS |
≤10PPM |
|
RESIDUE ON IGNITION |
≤0.1% |
|
ETHANOL |
≤0.5% |
|
METHYLENE CHLORIDE |
≤0.06% |
|
TOLUENE |
≤0.089% |
|
METHANOL |
≤0.3% |
|
ETHYL ACETATE |
≤0.5% |
|
PARTICLE SIZE |
D(0.9) NOT MORE THAN 10UM |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
