PRODUCT NAME

ISOSORBIDE

PACKAGE

25KG/DRUM

BATCH NO.

201000610

BATCH SIZE

8000KGS

DATE OF MANUFACTURE

20100610

DATE OF ANALYSIS

20100611

TEST

ACCEPTANCE CRITERIA

RESULTS

DESCRIPTION

White Crystals or Masses, Hygroscopic

White Crystals, Hygroscopic

Identification

Chemical Reaction

An Orange Precipitate is Formed

An Orange Precipitate is Formed

MP

102~103°C

102.6°C

IR

Exhibiting the similar intensities of absorption at the same wave number as the reference spectrum

Conform

Optical Rotation

+45.0°~+46.0°

+45.9°

Purity

Clarity and Color of Solution

The solution is clear and has no more color than the control solution

Conform

Sulfate

Not more than 0.024%

Less than 0.024%

Heavy Metals

Not more than 5ppm

Less than 5ppm

Arsenic

Not more than 2ppm

Less than 2ppm

Related Substances

The spots other than the principal spot from the sample solution are not more intense than the spot from the standard spot

Conform

Water

Not more than 1.5%

0.30%

Residue on ignition

Not more than 0.10%

0.01%

Assay

Not less than 98.5%

100.88%

Conclusions: the batch of Isosorbide conforms to JP.XV