135062-02-1 Repaglinide 4-Ethoxycarbonyl-3-ethoxy phenyl acetic acid
Production Name:Repaglinide
Items
|
Specifications
|
Results
|
Appearance
|
White to off-white crystalline powder
|
White Powder
|
Water
|
5.8%—6.5%
|
6.1%
|
Related Substances
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Single impurity ≤0.1%
|
0.02%
|
Total impurities ≤0.3%
|
0.03%
|
|
Granularity
|
Particle size
D50≤6.0μm D90≤12.5μm |
Complies
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Residue on ignition
|
≤0.1%
|
0.06%
|
Heavy metals
|
≤20ppm
|
Complies
|
Residual solvents
|
Match with the standard of USP32
|
Complies
|
Assay
|
≥99.5%
|
99.8%
|
Conclusion
|
Complies to the enterprise standard.
|
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