Detailed Acarbose Description:
Appearance: white to yellowish, amorphous powder hygroscopic.
Solubility: very soluble in water, soluble in methanol, practically insoluble in methylene chloride.
Heavy metal: Maximum 0.002 percent.
PH-value: 5 -7.
Specific rotation 20D: +168-+183
Sulphated ash: Maximum 0.2 percent
Water: Maximum 2 percent
Identity: Test A(IR) To comply ; test C(HPLC) To comply
Unknown single impurity Maximum 0.1 percent
Knownrelated substance impurity A Maximum 0.6 percent
impurity B Maximum 0.5percent
impurity C Maximum 1.5 percent
impurity D Maximum 1.0 percent
Impurity E Maximum 0.2 percent
impurity F Maximum 0.3 percent
impurity G Maximum 0.2 percent
impurity H Maximum 0.2 percent
Total impurities Maximum 3.0 percent
Assay On the dried substance Min 97percent Maximum 102 percent
Absorbance: Max 0.15 at 425nm
Granularity: Min.100 mesh
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