Test  Item

Analysis  Specification

Result

Description

White to almost white crystal

White to almost white crystal

Identification

A: IR spectra shows the similarity between sample and standard

B: The retention time of the major peak corresponds with it of the reference standard

Complies

Complies

Solution color and clearness

Colorless to pale-yellow clear solution

Complies

Chlorides

Not more than 0.053%

<0.053%

Sulphate

Not more than 0.011%

<0.011%

Loss on drying

Not more than 1.5%

0.66%

Heavy metals

Not more than 0.002%

<0.002%

Related Substances

TMP :Not more than 0.15%

Benzoic acid :not more than0.1%

Amide: not more than 0.40%

Single unknown impurity: not more than0.1%

Thiamine: not more than0.1%

Total impurities: Not more than 1.5%

<0.025%

No detectable

0.06%

0.08%

No detectable

0.33%

Residual solvents

Dichloromethane: not more than 600ppm

Isopropanol: not more than300ppm

No detectable

64ppm

Microbial limits

Total bacteria: not more than100cfu/g

Yeast and mould: not more than50cfu/g

Escherichia coli: no detectable

<10 cfu/g

<10 cfu/g

No detectable

Assay(Dry Basis)

98.0%~102.0%

99.6%

Conclusion

Complies with company Standard.