INDENTIFICATION IR ABSORPTION   SPECTROPHOTOMETRY

COMPARES TO REFERENCE SPECTRUM

TLC

CORRESPONDS WITH REFERENCE CHROMATOGRAM

APPEARANCE OF SOLUTION

CLEAR AND ≤BY6

ACIDITY OR ALKALINITY

≤0.05ML OF 0.1 M HCL OR 0.1 M NAOH

IMPURITY-HPLC

0.05%mas

RELATED SUBSTANCES

IMPURITY B:

0.1%max

IMPURITY C:

0.4%max

IMPURITY E:

0.2%max

UNSPECIFIED IMPURITIES:

0.1%max

WATER

0.5%max

ASSAY-HPLC

(ANHYDROUS SUBSTANCE)

97.0%-102.0%