SHELF LIFE

3 years

ITEMS

SPECIFICATIONS

RESULTS

APPEARANCE

WHITE TO ALMOST   WHITE CRYSTALLINE POWDER

WHITE CRYSTALLINE   POWDER

IDENTIFICATION

A.INFRARED   ABSORPTION

THE INFRARED   ABSORPTION SPETRUM IS CONCORDANT WITH THE REFERENCE SPECTRUM

COMPLIES

B. ULTRAVIOLET   ABSORPTION

ABSORPTIVITIES AT   2725NM,CALCULATED ON THE DRIED BASE, DO NOT DIFFER BY MORE THAN 3%

1%

SPECIFIC    ROTATION

-17° -- -15.3°

-16.8°

LOSS ON DRYING

≤1.0%

0.1%

HEAVY METALS

≤0.002%

<0.002%<   td="">

FREE NAPROXEN

≤1.0%

0.1%

RELATED   SUBSTANCES(HPLC)

IMPURITY D(IN-HOUSE)

≤ 0.1%

<0.01%<   td="">

IMPURITY E   (IN-HOUSE,IMPUROTI C ON EP)

≤ 0.1%

<0.01%<   td="">

ANY OTHER IMPURITY

≤ 0.1%

<0.01%<   td="">

TOTAL IMPURITIES

≤ 0.5%

<0.01%<   td="">

RESIDUAL SOLVENTS

TOLUENE

≤50PPM

<1ppm<   td="">

METHANOL

≤50PPM

<4ppm<   td="">

ASSAY (ON DRIED   BASIS) 

IT CONTAINS   C14H13NAO3 98.5%-101.5%

99.3%

CONCLUSION

COMPLIES WITH USP38   STANDARD