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 | <= 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 | <= 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 | <= 0.02 % |
JP - Related Substances - Total other peaks >RT of benzyl alcohol | <= 0.2 % |
JP - Peroxide Value | <= 5 |
JP - Residue on Evaporation | <= 0.05 % |
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