CAS number： 1695-77-8
Molecular formula： C14H25ClN2O7
molecular weight： 368.8105
Chemical structure：
| Name of Product: | Spectinomycin Sulphate Tetrahydrate | |
| Shelf Life: | 3 years | |
| Test Items | Specification | Results of Analysis |
| Characters | ||
| Appearance | White or almost white powder | Conforms |
| Solubility | Freely soluble in water, insoluble in ethanol (96 percent) | Conforms |
| Identification | ||
| A.IR Spectrophotometry | Meet the requirements | Conforms |
| B.Reaction (a) of Sulphates | Meet the requirements | Conforms |
| Appearance of Solution | Clear and colourless | Conforms |
| PH | 3.8-5.6 | 4.4 |
| Specific Optical Rotation | +10.0° to +14.0° | +11.9° |
| Related Substances | ||
| Impurity A | ≤1.0% | 0.48% |
| Impurity E | ≤1.0% | 0.61% |
| Impurity D | ≤4.0% | 0.21% |
| Any other impurity | ≤1.0% | 0.20% |
| Total Impurities | ≤6.0% | 1.7% |
| Water (K.F.) | 12.0% to 16.5% | 14.8% |
| Sufated Ash | ≤1.0% | 0.23% |
| Assay (Anhydrous Substance) | ||
| -(4R)-Dihydrospectinomycin Sulfate | ≤2.0% | 1.6% |
| -Spectinomycin Sulfate And (4R)-Dihydrospectinomycin Sulfate | 93.0% to 102.0% | 97.8% |
| Residual Solvents (Acetone) | ≤0.3% | 0.03% |
| Additional Tests | ||
| Heavy Metals | ≤20ppm | ＜20ppm |
| Sulfate | 21.0% to 26.0% | 23% |
| Microbial Limits | ||
| Total Bacteria Count | ≤500cfu/g | ＜1cfu/g |
| Total Moulds and Yeasts | ≤50cfu/g | ＜1cfu/g |
| Escherichia Coli | Absence | Undetected |
