Tests Item

Standard

Appearance

Off-white to tan crystalline powder; No visible evidence of contamination by foreign matter.

Identification

HPLC

IR spectrum exhibits maxima only at the same wavelengths as that of a similar preparation of the reference standard.

IR

The retention time of the sample test solution corresponds to that of the standard solution.

Water

Not more than 2.0%

Heavy metals

Not more than 0.002%

Residue on ignition

Not more than 0.2%

Related Substances

Individual Unknown

Not more than 0.1%

Milrinone Amide

Not more than 0.2%

Total Impurities

Not more than 0.5%

Residual Solvents

Ethanol

Not more than 1500ppm

Ether

Not more than 100ppm

DMF

Not more than 250ppm

Organic Volatile Impurities

Chloroform

Not more than 60ppm

Assay (Calculated on the anhydrous)

Not less than 98.5%  and not more than 101.5%