Résultats des tests de spécification
Meets B.P. Chemical Specifications |
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Meets U.S.P Requirements |
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Meets J.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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GMP Manufactured Product |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
Passes Test |
USP - Identification A |
Passes Test |
USP - Identification B |
Passes Test |
USP - Specific Gravity at 25°/25°C |
0.783 - 0.787 |
USP - Refractive Index, n²ºD |
1.376 - 1.378 |
USP - Acidity |
Passes Test |
USP - Nonvolatile Residue |
≤0.005 % |
USP - Assay |
≥99.0 % |
USP - Water (H₂O) |
≤0.5 % |
USP - Volatile Impurities - Ethyl ether |
≤0.1 % |
USP - Volatile Impurities - Acetone |
≤0.1 % |
USP - Volatile Impurities - Diisopropyl ether |
≤0.1 % |
USP - Volatile Impurities - 1-Propanol |
≤0.1 % |
USP - Volatile Impurities - 2-Butanol |
≤0.1 % |
USP - Volatile Impurities - Total |
≤1.0 % |
USP - Benzene |
≤2 ppm |
EP/BP - Identification B |
Passes Test |
EP/BP - Identification C |
Passes Test |
Appearance |
Passes Test |
EP/BP - Acidity or Alkalinity |
Passes Test |
EP/BP - Benzene (C₆H₆) |
≤2 ppm |
EP/BP - Any peak other than 2-butanol |
≤0.3 % |
EP/BP - Peroxide |
Passes Test |
EP/BP - Nonvolatile Matter |
≤20 ppm |
EP/BP - Water (H₂O) |
≤0.5 % |
EP/BP - UV Absorbance - 310 nm |
≤0.01 |
EP/BP - UV Absorbance - 290 nm |
≤0.02 |
EP/BP - UV Absorbance - 270 nm |
≤0.03 |
EP/BP - UV Absorbance - 250 nm |
≤0.10 |
EP/BP - UV Absorbance - 230 nm |
≤0.30 |
EP/BP - Spectrum Appearance |
Passes Test |
JP - Identification A |
Passes Test |
JP - Identification B |
Passes Test |
JP - Specific Gravity at 20°/20°C |
0.785 - 0.788 |
JP - Clarity of Solution |
Passes Test |
JP - Acidity |
Passes Test |
JP - Residue on Evaporation, mg/20mL |
≤1.0 |
JP - Water (H₂O) |
≤0.75 % |
JP - Distilling Range(Lower) |
81 - 83 °C |
JP - Distilling Range (Upper) |
81 - 83 °C |
Residual solvents – Only the Class 2 solvent cyclohexane and Class 3 |
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solvents are likely to be present. Cyclohexane is controlled below the |
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USP 467 Option 1 limit. All Class 3 solvents are less than 0.5%. |
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