| 检测方法 |
规格范围 |
| Food GMP Manufactured Product |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets F.C.C. Requirements |
| Meets J.P. Chemical Specifications |
| Meets U.S.P Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Food Chemical |
| Bulk Pharmaceutical Chemical |
| USP - Assay (C₅H₁₁NO₂S) (dried basis) |
98.5 - 101.5 % |
| USP - Identification |
Passes Test |
| USP - Specific Rotation [Å]2⁵ ^D (+) |
22.4 - 24.7 Degree |
| USP - pH |
5.6 - 6.1 |
| USP - Loss on Drying at 105°C |
<= 0.3 % |
| USP - Residue on Ignition |
<= 0.4 % |
| USP - Chloride (Cl) |
<= 0.05 % |
| USP - Sulfate (SO₄) |
<= 0.03 % |
| USP - Iron (Fe) |
<= 0.003 % |
| USP - Related Compounds - Individual Impurities |
<= 0.5 % |
| USP - Related Compounds - Total Impurities |
<= 2.0 % |
| USP - Heavy Metals (as Pb) |
<= 0.0015 % |
| FCC - Assay (C₅H₁₁NO₂S) (dried basis) |
98.5 - 101.5 % |
| FCC - Identification |
Passes Test |
| FCC - Lead (Pb) |
<= 5 mg/kg |
| FCC - Loss on Drying at 105°C |
<= 0.5 % |
| FCC - Residue on Ignition |
<= 0.1 % |
| FCC - Specific Rotation [Å]2o^D (+) |
21.0 - 25.0 Degree |
| FCC - Insoluble Foreign Matter |
Passes Test |
| EP/BP - Assay (C₅H₁₁NO₂S) (dried basis) |
99.0 - 101.0 % |
| EP/BP - Identification A |
Passes Test |
| EP/BP - Identification B |
Passes Test |
| EP/BP - Appearance of Solution |
Passes Test |
| EP/BP - pH |
5.5 - 6.5 |
| EP/BP - Specific Rotation [Å]2o^D (+) |
22.5 - 24.0 Degree |
| EP/BP - Related Substances: Unspecified Impurities, each |
<= 0.10 % |
| EP/BP - Related Substances: Total Impurities |
<= 0.3 % |
| EP/BP - Chloride (Cl) |
<= 200 ppm |
| EP/BP - Sulfate (SO₄) |
<= 300 ppm |
| EP/BP - Ammonium (NH₄) |
<= 200 ppm |
| EP/BP - Heavy Metals (as Pb) |
<= 10 ppm |
| EP/BP - Iron (Fe) |
<= 10 ppm |
| EP/BP - Loss on Drying at 105°C |
<= 0.5 % |
| EP/BP - Ash (sulfated) |
<= 0.1 % |
| JP - Assay (C₅H₁₁NO₂S) (dried basis) |
98.5 - 101.0 % |
| JP - Identification |
Passes Test |
| JP - Optical Rotation (+) |
21.0 - 25.0 Degree |
| JP - pH |
5.2 - 6.2 |
| 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 after Ignition |
<= 0.10 % |
| Endotoxin Concentration, IU/mg, For Information Only |
| Only Class 2 Solvents (Methanol) are likely to be present. All are |
| below Option 1 limits. |
| Metallic Residues: No metal catalysts or metal reagents, as defined by |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of |
| this material. |