Specification Test Results
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 |
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 |
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 |
JP - Related Substances - Total other peaks >RT of benzyl alcohol |
≤0.2 % |
JP - Peroxide Value |
≤5 |
JP - Residue on Evaporation |
≤0.05 % |
Total Aerobic Microbial Count |
≤100 cfu/g |
Total Yeast and Mold Count |
≤10 cfu/g |
Endotoxin Concentration, EU/mL |
≤2.5 |
Arsenic (As), For Information Only |
|
Cadmium (Cd), For Information Only |
|
Lead (Pb), For Information Only |
|
Mercury (Hg), For Information Only |
|
Nickel (Ni), For Information Only |
|
Cobalt (Co), For Information Only |
|
Vanadium (V), For Information Only |
|
Chromium (Cr), For Information Only |
|
Copper (Cu), For Information Only |
|
Gold (Au), For Information Only |
|
Iridium (Ir), For Information Only |
|
Osmium (Os), For Information Only |
|
Palladium (Pd), For Information Only |
|
Platinum (Pt), For Information Only |
|
Rhodium (Rh), For Information Only |
|
Ruthenium (Ru), For Information Only |
|
Selenium (Se), For Information Only |
|
Silver (Ag), For Information Only |
|
Thallium (Tl), For Information Only |
|
Antimony (Sb), For Information Only |
|
Barium (Ba), Barium (Ba), FIO |
|
Lithium (Li), For Information Only |
|
Molybdenum (Mo), For Information Only |
|
Tin (Sn), For Information Only |
|
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. |
|