| 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. |