Résultats des tests de spécification
Meets B.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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Meets N.F. Requirements |
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Meets J.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 |
98.0 - 100.5 % |
NF - Assay (C₆H₅CH₂OH) |
98.0 - 100.5 % |
NF - Clarity of Solution |
Passes Test |
NF - Color of Solution |
Passes Test |
NF - Identification |
Passes Test |
NF - Peroxide Value |
≤5 |
NF - Benzaldehyde and Other Related Substances - Benzaldehyde |
≤0.15 % |
NF - Related Substances - Cyclohexylmethanol |
≤0.10 % |
of Benzyl Alcohol |
≤0.04 % |
NF - Benzaldehyde and Other Related Substances - Total Other Peaks |
NF - Benzaldehyde and Other Related Substances - Total Other Peaks |
≤0.3 % |
Greater Than RT of Benzyl Alcohol |
≤0.3 % |
NF - Refractive Index, n²ºD |
1.538 - 1.541 |
NF - Acidity |
Passes Test |
NF - Residue on Evaporation |
≤0.05 % |
NF - Benzene |
≤2 ppm |
Solubility |
Passes Test |
EP/BP - Assay (C₆H₅CH₂OH) |
98.0 - 100.5 % |
EP/BP - Identification |
Passes Test |
EP/BP - Acidity |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Refractive Index, n²º^D |
1.538 - 1.541 |
EP/BP - Benzaldehyde and Other Related Substances - Benzaldehyde |
≤0.15 % |
EP/BP - Related Substances - Cyclohexylmethanol |
≤0.10 % |
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EP/BP - Benzaldehyde and Other Related Substances - Total Other Peaks |
≤0.04 % |
EP/BP - Benzaldehyde and Other Related Substances - TOTAL OTHER PEAKS |
≤0.3 % |
>RT OF BENZYL ALCOHOL |
≤0.3 % |
EP/BP - Peroxide Value |
≤5 |
EP/BP - Residue on Evaporation |
≤0.05 % |
JP - Assay (C₆H₅CH₂OH) |
98.0 - 100.5 % |
JP - Identification |
Passes Test |
JP - Refractive Index, n²º^D |
1.538 - 1.541 |
JP - Specific Gravity at 20°/20°C |
1.043 - 1.049 |
JP - Clarity and Color of Solution |
Passes Test |
JP - Acidity |
Passes Test |
JP - Benzaldehyde and Other Related Substances - Benzaldehyde |
≤0.15 % |
JP - Related Substances - Cyclohexylmethanol |
≤0.10 % |
JP - Benzaldehyde and Other Related Substances - Total Other Peaks |
OF BENZYL ALCOHOL |
≤0.3 % |
JP - Benzaldehyde and Other Related Substances - TOTAL OTHER PEAKS >RT |
≤0.3 % |
JP - Peroxide Value |
≤5 |
JP - Residue on Evaporation |
≤0.05 % |
This product is not intended for use in preparing parenteral dosage |
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forms. |
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The Class 1 solvent Benzene is likely to be present below 2 ppm. The |
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actual analysis of Benzene is reported for each lot. |
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The Class 2 solvent Toluene is likely to be present and is process |
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controlled to <30 ppm. |
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No other Class 1, 2 or 3 residual solvents are likely to be present. |
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