Product Brief Introduction
Product name: Rotigotine
CAS: 99755-59-6
MF: C19H25NOS
MW: 315.48
Product Specification
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Appearance |
White or slight-brown powder |
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Identification |
IR: the infrared absorption spectrum of the sample complies with the reference standard. |
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LC: in the chromatogram recorded under the enantiomers section, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the system suitability solution. |
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Solubility |
Soluble in anhydrous ethanol, practically insoluble in water and n-heptane. |
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Moisture |
≤ 0.2% |
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Residue on Ignition |
≤ 0.1% |
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Sulfate (SO42-) |
≤ 0.1% |
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Chloride (Cl-) |
≤ 0.1% |
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Related Substances |
Rotigatin Impurity A ≤ 0.15% |
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Rotigatin Impurity B ≤ 0.15% |
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Rotigatin Impurity C ≤ 0.2% |
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Rotigatin Impurity D ≤ 0.15% |
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Rotigatin Impurity G ≤ 0.15% |
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Other single impurity ≤ 0.1% |
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Total impurities ≤ 0.6% |
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Heavy Metals |
≤ 10ppm |
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Residual Solvents |
Methanol ≤ 0.3% |
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Dichloromethane ≤ 0.06% |
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Acetone ≤ 0.5% |
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Ethyl acetate ≤ 0.5% |
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Cyclohexane ≤ 0.388% |
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Toluene ≤ 0.089% |
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Benzene ≤ 0.0002% |
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Isopropanol ≤ 0.5% |
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Total Aerobic Microbial Count |
≤ 1000cfu/g |
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Yeasts & Molds |
≤ 100cfu/g |
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Staphylococcus Aureus |
Negative/1g |
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Pseudomonas Aeruginosa |
Negative/1g |
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Assay (on anhydrous basis) |
98.0%~102.0% |
