| 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 - Identification |
Passes Test |
| USP - Loss on Drying at 105°C |
<= 0.2 % |
| USP - Residue on Ignition |
<= 0.1 % |
| USP - Chloride (Cl) |
<= 0.007 % |
| USP - Sulfate (SO₄) |
<= 0.0065 % |
| USP - Hydrolyzable Substances |
Passes Test |
| USP - Assay (C₂H₅NO₂) (dried basis) |
98.5 - 101.5 % |
| USP - Endotoxin Concentration (EU/g) |
<= 2.5 |
| EP/BP - Assay (C₂H₅NO₂) (dried basis) |
98.5 - 101.0 % |
| EP/BP - Identification A |
Passes Test |
| EP/BP - Appearance of Solution |
Passes Test |
| EP/BP - pH |
5.9 - 6.4 |
| EP/BP - Chloride (Cl) |
<= 75 ppm |
| EP/BP - Loss on Drying at 105°C |
<= 0.5 % |
| EP/BP - Ash (sulfated) |
<= 0.1 % |
| EP/ BP - Related substances: Glycine anhydride |
<= 0.10 % |
| EP/ BP - Related substances: Diglycine |
<= 0.10 % |
| EP/ BP - Related substances: Triglycine |
<= 0.10 % |
| EP/ BP - Related substances: Unspecified impurities, each |
<= 0.10 % |
| EP/ BP - Related substances: Total impurities |
<= 0.2 % |
| EP/BP - Ninhydrin Positive Substances - Each Impurity |
<= 0.10 |
| EP/BP-Ninhydrin-Positive Substances-Total Impurities |
<= 1.0 % |
| EP/BP - Ammonium (NH₄) |
<= 0.02 % |
| JP - Assay (C₂H₅NO₂) (dried basis) |
98.5 - 101.0 % |
| JP - Identification |
Passes Test |
| JP - pH (1 in 20) |
5.6 - 6.6 |
| JP - Clarity and Color of Solution |
Passes Test |
| JP - Chloride (Cl) |
<= 0.021 % |
| JP - Sulfate (SO₄) |
<= 0.028 % |
| JP - Ammonium (NH₄) |
<= 0.02 % |
| JP - Heavy Metals (as Pb) |
<= 20 ppm |
| JP - Arsenic (As) |
<= 2 ppm |
| JP - Related Substances |
Passes Test |
| JP - Loss on Drying at 105°C |
<= 0.30 % |
| JP - Residue on Ignition |
<= 0.10 % |
| Only Class 2 Solvents (Methanol) are likely to be present. All are |
| below Option 1 limits. |
|
| Elemental Impurities (USP <(><<)>232>, EP 5.20) - Information on |
| elemental impurities for this product is available on the associated |
| Product Regulatory Data Sheet and elemental impurity profile report. |