Nicorandil

Product Name

NICORANDIL

Test   Date

2013.05.15

Batch  NO.

20130504

Report  Date

2013.05.20

Quantity

20kg

MFG  Date

2013.05.11

Specification

WS-10001-(HD-0150)-2002

Retest  Date

2015.05.10

Items

Limits

Results

Description

White,crystalline powder

White,crystalline powder

Melting point

88.5~93.5°C

92.5~93.0°C

Identifications

Color reaction

The test solution should present brown

Conforms

Maxium absorbance at 262nm

Presents Maxium absorbance at 262nm

Conforms

IR

The infrared spectrum of the test substance corresponds to the standard spectrum.

Conforms

Loss on drying

≤0.5%

0.04%

Residue on ignition

≤0.1%

0.05%

Sulphates

≤0.02%

<0.02%

Related substances

≤1.0%

<1.0%

Acidity

The test solution should present pink

Conforms

Heavy metals

≤0.0020%

<0.0020%

Residual  Solvent

Toluol≤0.089%

Undetected

Acetone≤0.50%

Undetected

Ethanol  ≤0.50%

Undetected

 Microbial limit

Total Aerobic Microbial Count≤1000CFU/g

Molds and yeasts count≤100CFU/g

Escherichia coli:Absent

20CFU/g

<10CFU/g

Absent

Assay

98.5%~101.0%

(Calculated on the dried substance C8H9N3O4)

99.8%

Conclusion

The product meets the requirements of the specification