2,6-Dimethyl-5-Methoxycarbonyl-4-(3-Nitrophenyl)-1

Tests

Requirements

Results

Description

White or Yellow Powder

Confirmed

Solubility

Soluble in 1N NaOH. Slightly soluble in DMF and Practically Insoluble in water

Confirmed

Water Content (By KF)

Not more than 0.5% w/w

0.32%w/w

Identification

A)    By UV

UV absorption of the sample must be concordant with the standard spectrum.

Confirmed

B)    By IR

IR absorption of the sample must be concordant with the standard spectrum.

Confirmed

Residue after Ignition

Not more than 0.2% w/w

0.07%w/w

Heavy metals

Not more than 20 ppm

Less than 20 ppm

Related substances (by HPLC)

Individual known impurity

Individual unknown impurity

Total impurities

Not more than 0.5%

Not more than 0.5%

Not more than 1.0%

ND

0.18%

0.38%

Assay (By HPLC, on dried base)

Not less than 98.0%

99.10%w/w

Conclusion

The material complies with respect to the above specification