| PRODUCT NAME | CLARITHROMYCIN | |
| Shelf Life | 4 years | |
| ITEMS | SPECIFICATIONS | RESULTS |
| APPEARANCE | WHITE TO ALMOST WHITE,CRYSTALLINE POWDER | COMPLIES |
| SPECIFIC ROTATION | -94° TO -102°(20℃) | -96.9° |
| IDENTIFICATION | IR SPECTRUM CORRESPONDS TO | COMPLIES |
| CRYSTALLINITY | MEETS THE REQUIREMENTS | COMPLIES |
| PH | 8.0-10.0 | 8.4 |
| WATER | NOT MORE THAN 2.0% | 0.3% |
| RESIDUE ON IGNITION | NOT MORE THAN 0.2% | 0.02% |
| HEAVY METALS | NOT MORE THAN 20UG/G | COMPLIES |
| PARTICLE SIZE | 40MESHES | COMPLIES |
| RESIDUAL SOLVENTS | ETHANOL NOT MORE THAN 5000PPM | 300PPM |
| PYRIDINE HYDROCHLORIDE SHOULD NOT DETECTED | ND | |
| RELATED SUBSTANCES | IMPURITY I NOT MORE THAN 1.0% | ND |
| IMPURITY A NOT MORE THAN 1.0% | ND | |
| IMPURITY J NOT MORE THAN 1.0% | ND | |
| IMPURITY L NOT MORE THAN 1.0% | ND | |
| IMPURITY B NOT MORE THAN 1.0% | ND | |
| IMPURITY M NOT MORE THAN 1.0% | 0.06% | |
| IMPURITY C NOT MORE THAN 1.0% | ND | |
| IMPURITY D NOT MORE THAN 1.0% | ND | |
| IMPURITY N NOT MORE THAN 1.0% | ND | |
| RELATED COMPOUND A NOT MORE THAN 1.0% | ND | |
| IMPURITY F NOT MORE THAN 1.0% | 0.27% | |
| IMPURITY P NOT MORE THAN 1.0% | ND | |
| IMPURITY O NOT MORE THAN 1.0% | ND | |
| IMPURITY K NOT MORE THAN 1.0% | ND | |
| IMPURITY G NOT MORE THAN 1.0% | ND | |
| IMPURITY H NOT MORE THAN 1.0% | ND | |
| Any individual impurity not more than 1.0% | 0.6% | |
| Impurity exceed 0.4% not more than 4 | 2 | |
| Total impurities not more than 3.5% | 2.8% | |
| ASSAY | 96.0—102.0% ON ANHYDROUS BASIS | 97.7% |
| CONCLUSION | THIS BATCH OF PRODUCT IS IN CONFORMANCE WITH USP38 | |