| PRODUCT NAME | NAPROXEN SODIUM | |
| 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 | |