Item

Analysis standard

Analysis results

Charachteristics

White or almost white crystalline powder

pass

Identification

Positive reaction

Positive

Melting point

About 190

191

Ph

2.1-2.6

2.4

Clarity of solution

Clear

Clear

Colour of solution

≤BY7

BY7

Copper

≤5ppm

5ppm

Heavy metals

≤10ppm

10ppm

Lead  

≤2ppm

2ppm

Iron

≤2ppm

2ppm

Oxalic acid

≤0.2%

0.2%

Suphate ash(Residue on ignition)

≤0.1%

0.05%

Spcific optical rotation

+20.5°- +21.5°

+20.9°

Assay

99.0%-100.5%

99.9%

Organic volatile impurities

Pass

Pass

Residual Solvents

Methanol NMT 3000ppm

3000ppm

Conclusion :The above product conforms to BP2005 , USP29,EPV,FCCV