检测方法 |
规格范围 |
GMP Manufactured Product |
Meets B.P. Chemical Specifications |
Meets E.P. Chemical Specifications |
Meets J.P. Chemical Specifications |
Meets U.S.P Requirements |
CAUTION: For Manufacturing, processing or repackaging |
Bulk Pharmaceutical Chemical |
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 |
<= 0.10 % |
USP - Identification B - Ethylene Glycol |
<= 0.10 % |
USP - Identification C |
Passes Test |
USP - Residue on Ignition |
<= 0.007 % |
USP - Chloride (Cl) |
<= 0.007 % |
USP - Sulfate (SO₄) |
<= 0.006 % |
USP - Heavy Metals (as Pb) |
<= 5 ppm |
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 - Heavy Metals (as Pb) |
<= 5 ppm |
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 % |
No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |