Résultats des tests de spécification
GMP Manufactured Product |
98.5 - 101.5% |
Meets B.P. Chemical Specifications |
Passes Test |
Meets E.P. Chemical Specifications |
22.4 - 24.7 Degree |
Meets J.P. Chemical Specifications |
5.6 - 6.1 |
Meets U.S.P Requirements |
≤0.3% |
CAUTION: For Manufacturing, processing or repackaging |
≤0.4% |
Bulk Pharmaceutical Chemical |
≤0.05% |
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 - Methionine sulfoxide |
≤0.1 % |
USP - Related Compounds - N-Acetyl-D,L- methionine |
≤0.2 % |
USP - Related Compounds - Any unspecified impurity |
≤0.1 % |
USP - Related Compounds - Total unspecified impurities |
≤0.30 % |
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 - 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 |
|
Metallic Impurities - Cobalt (Co), For Information Only |
|
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. |
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