| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets J.P. Chemical Specifications |
| Meets N.F. Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| 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% |
| NF - Benzaldehyde and Other Related Substances - Total Other Peaks <RT |
<= 0.04% |
| of Benzyl Alcohol |
<= 0.04% |
| Greater Than RT of Benzyl Alcohol |
<= 0.3% |
| NF - Benzaldehyde and Other Related Substances - Total Other Peaks |
<= 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% |
| <RT of Benzyl Alcohol |
<= 0.04% |
| EP/BP - Benzaldehyde and Other Related Substances - Total Other Peaks |
<= 0.04% |
| >RT OF BENZYL ALCOHOL |
<= 0.3% |
| EP/BP - Benzaldehyde and Other Related Substances - TOTAL OTHER PEAKS |
<= 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 <RT |
<= 0.04% |
| of Benzyl Alcohol |
<= 0.04% |
| JP - Benzaldehyde and Other Related Substances - TOTAL OTHER PEAKS >RT |
<= 0.3% |
| OF BENZYL ALCOHOL |
<= 0.3% |
| JP - Peroxide Value |
<= 5 |
| JP - Residue on Evaporation |
<= 0.05% |
| This product is not intended for use in preparing parenteral dosage forms. |
| The Class 1 solvent Benzene is likely to be present below 2 ppm. The actual analysis of Benzene is reported for each lot. |
| The Class 2 solvent Toluene is likely to be present and is process controlled to <30 ppm. |
| No other Class 1, 2 or 3 residual solvents are likely to be present. |