CAS 129618-40-2 Nevirapine

Item

Requirements

Test Results

Description

White to off- white crystalline powder

Complies

Light Absorption

Not more than 0.015(440nm,4cm cell, 50mg/ml)

Complies

Water

≤0.20% 

0.06%

Light absorption(50mg/ml,440nm,4cm)

≤0.0015

Complies

Limit of Lamivudine enantiomer

≤0.30% 

Not detected

Salicylic  acid

≤0.10% 

Not detected

Total impurities

≤0.60% 

0.14%

Other individual impurity

≤0.10% 

0.01%

Relative retention time at about 0.4 impurity

≤0.30% 

0.01%

Relative retention time at about 0.90 impurity

≤0.20% 

0.11%

Total residual solvents

≤0.3% 

0.14%

Ethanol

≤0.20% 

0.14%

n-Hexane

≤0.029% 

Not detected

Methylene dichloride

≤0.06% 

Not detected

TEA

≤0.10% 

Not detected

DMF

≤0.088% 

Not detected

Ethyl acetate

≤0.20% 

Not detected

Toluene

≤0.089% 

Not detected

Assay(On the anhydrous and solvent-free basis)

98.0%~102.0%

99.6%

Conclusion

Meets the Requirements