| 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 |
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- Related Substances - Benzaldehyde |
<= 0.05% |
| NF- Related Substances - Cyclohexylmethanol |
<= 0.10% |
| NF- Related Substances - Total Other Peaks <RT of Benzyl Alcohol |
<= 0.02% |
| NF- Related Substances - Total other peaks >RT of benzyl alcohol |
<= 0.2% |
| NF- Refractive Index, n²ºD |
1.538 - 1.541 |
| NF- Acidity |
Passes Test |
| NF- Residue on Evaporation |
<= 0.05% |
| Solubility |
Passes Test |
| EP/BP- Assay |
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, n²ºD |
1.538 - 1.541 |
| EP/BP- Peroxide Value |
<= 5 |
| EP/BP- Residue on Evaporation |
<= 0.05% |
| EP/BP- Related Substances - Benzaldehyde |
<= 0.05% |
| EP/BP- Related Substances - Cyclohexylmethanol |
<= 0.10% |
| EP/BP- Related Substances - Total Other Peaks <RT of Benzyl Alcohol |
<= 0.02% |
| EP/BP- Related Substances - Total other peaks >RT of benzyl alcohol |
<= 0.2% |
| JP- Assay |
98.0 - 100.5% |
| JP- Identification |
Passes Test |
| JP- Refractive Index, n²ºD |
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- Related Substances - Benzaldehyde |
<= 0.05% |
| JP- Related Substances - Cyclohexylmethanol |
<= 0.10% |
| JP- Related Substances - Total Other Peaks <RT of Benzyl Alcohol |
<= 0.02% |
| JP- Related Substances - Total other peaks >RT of benzyl alcohol |
<= 0.2% |
| JP- Peroxide Value |
<= 5 |
| JP- Residue on Evaporation |
<= 0.05% |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Suitable for use in the manufacture of parenteral dosage forms. |