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| Test | Specification | |
|---|---|---|
| Min | Max | |
| ASSAY (ANHYDROUS, SOLVENT-FREE BASIS) | 97 | 102.00% |
| SPECIFIC ROTATION, [a][@D@]25 | -49.0� to -55.0 | -49.0� to -55.0 |
| WATER DETERMINATION | 4.00% | |
| RESIDUE ON IGNITION | 0.20% | |
| HEAVY METALS | 0.00% | |
| BACTERIAL ENDOTOXINS | 0.4 USP E | |
| RELATED COMPOUNDS | TO PASS TEST | TO PASS TEST |
| MICROBIAL LIMITS: | ||
| TOTAL AEROBIC MICROBIAL COUNT | 100 cfu/g | |
| STAPHYLOCOCCUS AUREUS | 100 cfu/g | |
| PSEUDOMONAS AERUGINOSA | 100 cfu/g | |
| SALMONELLA | 100 cfu/g | |
| ESCHERICHIA COLI | 100 cfu/g | |
| IDENTIFICATION | TO PASS TEST | TO PASS TEST |
| DATE OF MANUFACTURE | ||
| APPEARANCE | ||
| RESIDUAL SOLVENTS | TO PASS TEST | TO PASS TEST |
