Specification Test Results
Meets U.S.P Requirements |
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GMP Manufactured Product |
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Meets J.P. Chemical Specifications |
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Meets B.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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USP - Specific Gravity at 25°/25°C |
1.035 - 1.037 |
USP - Acidity |
Passes Test |
USP - Water (H₂O)(by Karl Fischer titrn) |
≤ 0.2 % |
USP - Identification A (IR) |
Passes Test |
USP - Identification B - Diethylene glycol |
≤ 0.05 % |
USP - Identification B - Ethylene glycol |
≤ 0.05 % |
USP - Identification C |
Passes Test |
USP - Residue on Ignition |
≤ 0.007 % |
USP - Chloride (Cl) |
≤ 0.007 % |
USP - Sulfate (SO₄) |
≤ 0.006 % |
USP - Assay (CH₃CHOHCH₂OH) |
≥ 99.5 % |
Endotoxin Concentration (EU/g) |
≤ 2.5 |
EP/BP - Relative Density (d²º₂₀) |
1.035 - 1.040 |
EP/BP - Refractive Index at 20°C |
1.431 - 1.433 |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification B |
Passes Test |
EP/BP - Identification C |
Passes Test |
EP/BP - Identification D |
Passes Test |
EP/BP - Appearance |
Passes Test |
EP/BP - Acidity |
Passes Test |
EP/BP - Oxidizing Substances |
Passes Test |
EP/BP - Reducing Substances |
Passes Test |
EP/BP - Water (H₂O) |
≤ 0.2 % |
EP/BP - Ash (sulfated) |
≤ 0.01 % |
JP - Identification A |
Passes Test |
JP - Identification B |
Passes Test |
JP - Specific Gravity at 20°/20°C |
1.035 - 1.040 |
JP - Acidity |
Passes Test |
JP - Chloride (Cl) |
≤ 0.007 % |
JP - Sulfate (SO₄) |
≤ 0.002 % |
JP - Heavy Metals (as Pb) |
≤ 5 ppm |
JP - Arsenic (As) |
≤ 2 ppm |
JP - Glycerin |
Passes Test |
JP - Water (H₂O) |
≤ 0.5 % |
JP - Residue on Ignition |
≤ 0.005 % |
JP - Distilling Range (Lower) |
184 - 189 °C |
JP - Distilling Range (Upper) |
184 - 189 °C |
JP - Ethylene Glycol |
≤ 0.1 % |
JP - Diethylene Glycol |
≤ 0.1 % |
JP - Any Other Impurity |
≤ 0.1 % |
JP - Total Impurities |
≤ 1.0 % |
Microbial Testing – Total Aerobic Microbial Count (USP) |
≤ 10 cfu/mL |
Microbial Testing – Total Yeast and Mold Count (USP) |
≤ 10 cfu/mL |
Microbial Testing - Salmonella (USP) |
Negative |
Microbial Testing - Escherichia coli (USP) |
Negative |
Microbial Testing - Staphylococcus aureus (USP) |
Negative |
Microbial Testing - Pseudomonas aeruginosa (USP) |
Negative |
Microbial Testing -Bile tolerant gram-negative bacteria |
Negative |
Microbial Testing – Clostridia |
Negative |
Microbial Testing - Candida albicans |
Negative |
Trace Impurities - Cadmium (Cd) |
≤ 200 ppb |
Trace Impurities - Lead (Pb) |
≤ 500 ppb |
Trace Impurities - Arsenic (As) |
≤ 1500 ppb |
Trace Impurities - Mercury (Hg) |
≤ 300 ppb |
Trace Impurities - Cobalt (Co) |
≤ 500 ppb |
Trace Impurities - Vanadium (V) |
≤ 1000 ppb |
Trace Impurities - Nickel (Ni) |
≤ 2000 ppb |
Trace Impurities - Thallium (Tl) |
≤ 800 ppb |
Trace Impurities - Gold (Au) |
≤ 10000 ppb |
Trace Impurities - Palladium (Pd) |
≤ 1000 ppb |
Trace Impurities - Iridium (Ir) |
≤ 1000 ppb |
Trace Impurities - Osmium (Os) |
≤ 1000 ppb |
Trace Impurities - Rhodium (Rh) |
≤ 1000 ppb |
Trace Impurities - Ruthenium (Ru) |
≤ 1000 ppb |
Trace Impurities - Selenium (Se) |
≤ 8000 ppb |
Trace Impurities - Silver (Ag) |
≤ 1000 ppb |
Trace Impurities - Platinum (Pt) |
≤ 1000 ppb |
Trace Impurities - Lithium (Li) |
≤ 25000 ppb |
Trace Impurities - Antimony (Sb) |
≤ 9000 ppb |
Trace Impurities - Barium (Ba) |
≤ 70000 ppb |
Trace Impurities - Molybdenum (Mo) |
≤ 150000 ppb |
Trace Impurities - Copper (Cu) |
≤ 30000 ppb |
Trace Impurities - Tin (Sn) |
≤ 60000 ppb |
Trace Impurities - Chromium (Cr) |
≤ 110000 ppb |
No Class 1,2,3 or other solvents are used or produced in the |
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manufacturing or purification of the product. |
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Elemental Impurities (USP 232, EP 5.20) - Information on elemental |
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impurities for this product is available on the associated Product |
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Regulatory Data Sheet and elemental impurity profile report. |
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