Test

Reference Standard

USP/BP/FCC

Result

Appearance

White or almost white crystalline powder or crystals

Conforms

Identification

Infrared Absorption

Conforms

Solubility

Easily dissolve in water, slightly soluble in ethanol

Conforms

Melt point

92%- 96%

93.0%

Assay

98.5%-101.0%

99.68%

Other Polyol (on dry base)

≤ 1.0%

0%

Reducing Sugar

0.026%

Water

≤0.5%

0.11%

Residue on ignition

≤ 0.1%

0.020%

Heavy Metals

≤ 10 mg/kg

<5mg/kg

Lead

≤ 0.5 mg/kg

0.06 mg/kg

Nickel

≤ 1 mg/kg

0.06 mg/kg

Arsenic

≤ 3.0 mg/kg

0.04 mg/kg

pH in aqueous solution (10% w)

5.0-7.0

6.08

Total count

≤ 100 CFU/g

< 10CFU/g

Coliform

≤ 3MPN/g

<3 MPN/g

Yeast & Mold

≤ 100 CFU/g

< 10CFU/g

Conclusion

Conform to USP/BP/FCC standard