Ibuprofen
CAS Number: 15687-27-1
Molecular Formula: C13H17O2
Standard: USP32/BP2010/
Certificate: GMP
Documentation/Registration: FDA
Package: 25kg/drum
Ibuprofen
CAS Number: 15687-27-1
Molecular Formula: C13H17O2
Standard: USP32/BP2010/
Certificate: GMP
Documentation/Registration: FDA
Package: 25kg/drum
ITEMS | LIMIT |
CHARACTERISTICS | WHITE CRYSTALLINE POWDER |
SOLUBILITY | PRACTICALLY INSOLUBLE IN WATER;VERY SOLUBLE IN ALCOHOL,IN METHANOL,IN ACETONE,AND IN CHLOROFORM;SLIGHTLY SOLUBLE IN ETHYL ACETATE |
IDENTIFICATION: | A.SAMPLE UV SPECTRUM CORRESPONDS TO THAT OF THE STANDARD |
1. IR | |
2. UV | B.SAMPLE UV SPECTRUM DOES NOT DIFFER FROM THAT OF THE STANDARD BY MORE THAN 3.0% |
3. HPLC | C.RETENTION TIME CORRESPONDS TO THAT OF THE STANDARD |
WATER CONTENT | NOT MORE THAN 1.0% |
HEAVY METALS | NOT MORE THAN 0.002% |
RESIDUAL ON LGNITION | NOT MORE THAN 0.5% |
CHROMATOGRAPHIC PURITY | 2-[3-(2-METHYLPROPYL)PHENYL]PROPANOIC ACID:NOT MORE THAN 0.15% |
2-(4-METHYLPHENYL)PROPANOIC ACID:NOT MORE THAN 0.15% | |
2-(4-ETHYLPHENYL)PROPANOIC ACID:NOT MORE THAN 0.15% | |
2-(4-PROPYLPHENYL)PROPANOIC ACID:NOT MORE THAN 0.15% | |
2-(4-BUTYLPHENYL)PROPANOIC ACID:NOT MORE THAN 0.1% | |
ANY UNKNOWN IMPURITY:NOT MORE THAN 0.05% | |
TOTAL IMPURITIES:NOT MORE THAN 0.6% | |
4-ISOBUTYLACETOPHENONE | NOT MORE THAN 0.1% |
ASSAY(DRY BASIS) | 97.0%-103.0% |
ADDITIONAL TESTS | |
RESIDUAL SOLVENTS(PETROLEUM ETHER) | NOT MORE THAN 250PPM |
BULK DENSITY | 0.20-0.50G/ML |
TAPPED DENSITY | 0.40-0.70G/ML |
MEDIAN PARTICLE SIZE | 30-60UM |