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| Test | Specification | |
|---|---|---|
| Min | Max | |
| APPEARANCE | TO PASS TEST | TO PASS TEST |
| APPEARANCE/COLOR OF SOLUTION | TO PASS TEST | TO PASS TEST |
| ASSAY (HPLC, ANHYDROUS) | 97 | 102.00% |
| pH (10% AQUEOUS) | 4.5 | 6.5 |
| SPECIFIC ROTATION @ 20?? (ANHYDROUS) | +197 to +201??/td> | +197 to +201??/td> |
| WATER CONTENT (KF) | 9 | 11 |
| RELATED SUBSTANCES | TO PASS TEST | TO PASS TEST |
| HEAVY METALS | 5 ppm | |
| SULFATE | 200 ppm | |
| CHLORIDE | 125 ppm | |
| SOLUBLE STARCH | TO PASS TEST | TO PASS TEST |
| SULFATED ASH | 0.10% | |
| RESIDUAL SOLVENTS | TO PASS TEST | TO PASS TEST |
| BACTERIAL ENDOTOXINS | 2.5 EU/g | |
| MICROBIAL LIMITS | ||
| TOTAL AEROBIC MICROBIAL COUNT | 100 CFU/g | |
| TOTAL YEAST AND MOLD COUNT | 100 CFU/g | |
| ESCHERICHIA COLI | Negative | |
| SALMONELLA | Negative | |
| RETEST DATE | ||
