Résultats des tests de spécification
Meets J.P. Chemical Specifications |
Passes Test |
GMP Manufactured Product |
≤0.10% |
Meets U.S.P Requirements |
≤0.10% |
Meets B.P. Chemical Specifications |
Passes Test |
Meets E.P. Chemical Specifications |
99.0 - 101.0% |
CAUTION: For Manufacturing, processing or repackaging |
≥1.249 |
Bulk Pharmaceutical Chemical |
Passes Test |
USP - Identification A |
Passes Test |
USP - Identification B - Diethylene Glycol |
≤0.10 % |
USP - Identification B - Ethylene Glycol |
≤0.10 % |
USP - Identification C |
Passes Test |
USP - Assay (as HOCH₂CHOHCH₂OH) (calculated on anhydrous basis) |
99.0 - 101.0 % |
USP - Specific Gravity at 25°/25°C |
≥1.249 |
USP - Color |
Passes Test |
USP - Residue on Ignition |
≤0.01 % |
USP - Chloride (Cl) |
≤0.001 % |
USP - Sulfate (SO₄) |
≤0.002 % |
USP - Chlorinated Compounds (as Cl) |
≤0.003 % |
USP - Fatty Acids and Esters |
Passes Test |
USP - Water (H₂O) |
≤5.0 % |
USP - Related Compounds: Individual Impurity |
≤0.1 % |
USP - Related Compo unds: Total Impurities |
≤1.0 % |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification B |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Acidity or Alkalinity |
Passes Test |
EP/BP - Refractive Index, n²ºD |
1.470 - 1.475 |
EP/BP - Aldehydes |
≤10 ppm |
EP/BP - Ester |
Passes Test |
EP/BP - Halogenated Compounds |
≤35 ppm |
EP/BP - Sugars |
Passes Test |
EP/BP - Chloride (Cl) |
≤10 ppm |
EP/BP - Water (H₂O) |
≤2.0 % |
EP/BP - Ash (sulfated) |
≤0.01 % |
EP/BP - Impurity A and Related Substances - Impurity A |
≤0.1 % |
EP/BP - Impurity A and Related Substances - Other Impurities with R^T
≤0.1 % |
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EP/BP - Impurity A and Related Substances - Total Impurities R^T>Glycerol |
≤0.5 % |
EP - Assay (anhydrous basis) |
98.0 - 101.0 % |
JP - Assay (anhydrous basis) |
98.0 - 101.0 % |
JP - Identification |
Passes Test |
JP - Specific Gravity at 20°/20°C |
≥1.258 |
JP - Refractive Index, n²ºD |
≥1.470 |
JP - Color |
Passes Test |
JP - Residue on Ignition |
≤0.01 % |
JP - Chloride (Cl) |
≤0.001 % |
JP - Sulfate (SO₄) |
≤0.002 % |
JP - Heavy Metals (as Pb) |
≤5 ppm |
JP - Fatty Acids and Esters(as butyric acid) |
Passes Test |
JP - Readily Carbonizable Substances |
Passes Test |
JP - Acidity or Alkalinity |
Passes Test |
JP - Acrolein, Glucose, and Other Reducing Substances |
Passes Test |
JP - Ammonium (NH₄) |
Passes Test |
JP - Calcium (Ca) |
Passes Test |
JP - Arsenic (As) |
≤2 ppm |
JP - Water (H₂O) |
≤2.0 % |
JP - Ethylene Glycol |
≤0.1 % |
JP - Diethylene Glycol |
≤0.1 % |
JP - Any Other Impurity |
≤0.1 % |
JP - Total Impurities |
≤1.0 % |
Endotoxin Concentration (EU/g) |
≤5 |
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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