Macron™ 1403-10 Benzyl Alcohol, NF Grade, 4L Glass Bottle (Case of 4)
- 4 x 4L Glass Bottles/Case
- Manufacturer Part No: MK-1403-10
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Details
Product Specifications
TEST | SPECIFICATION |
Meets N.F. Requirements | |
GMP Manufactured Product | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
NF - Assay (C₆H₅CH₂OH) | 98.0 - 100.5 % |
NF - Acidity | Passes Test |
NF - Clarity of Solution | Passes Test |
NF - Color of Solution | Passes Test |
NF - Identification | Passes Test |
NF - Residue on Evaporation | <= 0.05 % |
NF - Peroxide Value | <= 5 |
NF - Refractive Index, n²ºD | 1.538 - 1.541 |
NF - Benzaldehyde and Other Related Substances - Benzaldehyde | <= 0.15 % |
NF - Benzaldehyde and Other Related Substances - Cyclohexylmethanol | <= 0.10 % |
NF - Benzaldehyde and Other Related Substances - Total Other Peaks Less | <= 0.04 % |
Than RT 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 - Benzene | <= 2 ppm |
Solubility | Passes Test |
The Class 1 residual solvent Benzene is likely to be present below 2 ppm. The actual analysis 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. | |
This product is not intended for use in preparing parenteral dosage forms. |
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Product Specifications
TEST | SPECIFICATION |
Meets N.F. Requirements | |
GMP Manufactured Product | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | |
NF - Assay (C₆H₅CH₂OH) | 98.0 - 100.5 % |
NF - Acidity | Passes Test |
NF - Clarity of Solution | Passes Test |
NF - Color of Solution | Passes Test |
NF - Identification | Passes Test |
NF - Residue on Evaporation | <= 0.05 % |
NF - Peroxide Value | <= 5 |
NF - Refractive Index, n²ºD | 1.538 - 1.541 |
NF - Benzaldehyde and Other Related Substances - Benzaldehyde | <= 0.15 % |
NF - Benzaldehyde and Other Related Substances - Cyclohexylmethanol | <= 0.10 % |
NF - Benzaldehyde and Other Related Substances - Total Other Peaks Less | <= 0.04 % |
Than RT 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 - Benzene | <= 2 ppm |
Solubility | Passes Test |
The Class 1 residual solvent Benzene is likely to be present below 2 ppm. The actual analysis 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. | |
This product is not intended for use in preparing parenteral dosage forms. |