TEST

SPECIFICATIONUSP29

RESULT

Appearance

White to off white crystalline powder

COMPLIES

Identification

1) IR: The Infrared Absorption Spectrum Is Concordant With the Reference standard

COMPLIES

2) TLC: The spot of test solution Is Concordant With the Reference standard

COMPLIES

        Melting point

189192ºC

190

       Loss on drying

≤0.5%

0.2%

       Heavy metal

≤20ppm

10ppm

     Specific optical rotation

     (20mg/ml, methanol)

-4.5º -6.0º

-5.5°

      Related substances (TLC)

Tran-4-cyclohexyl-L-proline

Cinchonidine

≤0.2%

≤0.2%

0.1%

0.1%

       Related substances (GC)

Trimethyl-acetic acid

2-ethyl caproic acid

≤0.2%

≤0.3%

0.1%

0.1%

     Related substances (HPLC)

Fosinoprilat

Any unidentified impurity

Total impurities

≤0.3%

≤0.1%

≤1.0%

0.15

0.07

0.8

             Residual solvents

Benzene

Dichloromethane

Acetonitrile

N-hexane

Chloroform

Toluene

Methanol

≤2ppm

≤600ppm

≤410ppm

≤290ppm

≤60ppm

≤890ppm

≤3000ppm

1 ppm

500 ppm

300 ppm

200 ppm

40 ppm

600 ppm

2000 ppm

Assay (calculated on dried basis)

98.5%101.5%

99.5%

Conclusion:

Up to Company standardUSP29