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Product Name |
Cabergoline |
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Batch No |
20230303 |
Mfg.Date |
2023-03-03 |
Annalysis Date |
2023-03-03 |
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Quantity |
500mg |
CAS No |
81409-90-7 |
Exp.Date |
2025-03-02 |
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Storage |
Preserve in tight containers.Shipment at normal temperature.For long time storage at +2℃~+8℃,must be tightly sealed,protect from air. |
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ITEM AND RESULT |
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Appearance |
White or almost white crystalline powder |
Complies |
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Identification |
1.IR complies |
Complies |
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2.X-Ray complies |
Complies |
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3.HPLC complies |
Complies |
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Loss on drying |
≤0.5% |
0.12% |
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Optical rotation |
-83.0°~ -77.0° |
-80.0° |
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Relate substances |
1.Impurity A≤0.15% |
0.02% |
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2.Impurity B≤0.10% |
0.02% |
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3.Impurity C≤0.30% |
0.05% |
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4.Impurity D≤0.10% |
0.02% |
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5.Other individual impurities ≤0.10% |
0.02% |
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6.Total impurities ≤0.80% |
0.12% |
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Residual Solvents |
1.Dichloromethane ≤100ppm |
30ppm |
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2.Acetone ≤200ppm |
20ppm |
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3.Ter-butylmethylether≤200ppm |
10ppm |
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4.Xylene≤1500ppm |
80ppm |
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5.Heptane≤1000ppm |
30ppm |
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Residue on ignition |
≤0.10% |
0.03% |
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Heavy metals |
≤20ppm |
1ppm |
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Particle size |
90% of particle size ≤80um |
Complies |
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Bulk density |
0.20~0.35g/cm3 |
0.33g/cm3 |
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Assay (on dry matter) |
98.0%~102.0% |
100.2% |
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conclusion |
Complies with in EP7.0/USP38 Standard. |
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