Résultats des tests de spécification
Meets U.S.P Requirements |
|
Meets B.P. Chemical Specifications |
|
Meets E.P. Chemical Specifications |
|
GMP Manufactured Product |
|
Meets J.P. Chemical Specifications |
|
CAUTION: For Manufacturing, processing or repackaging |
|
Bulk Pharmaceutical Chemical |
|
USP - Assay (C₆H₁₄N₄O₂) (dried basis) |
98.5 - 101.5 % |
USP - Identification |
Passes Test |
USP - Specific Rotation [Å]²⁵ ^D (+) |
26.3 - 27.7 Degree |
USP - Loss on Drying at 105°C |
≤ 0.5 % |
USP - Chloride (Cl) |
≤ 0.05 % |
USP - Residue on Ignition |
≤ 0.3 % |
USP - Sulfate (SO₄) |
≤ 0.03 % |
USP - Iron (Fe) |
≤ 0.003 % |
USP - Related Compounds - Individual Impurities |
≤ 0.5 % |
USP - Related Compounds - Total Impurities |
≤ 2.0 % |
EP/BP - Assay (C₆H₁₄N₄O₂) (dried basis) |
98.5 - 101.0 % |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification C |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Specific Rotation [Å]²º^D (+) |
25.5 - 28.5 Degree |
EP/BP-Ninhydrin-Positive Substances-Each |
≤ 0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities |
≤ 0.5 % |
EP/BP - Chloride (Cl) |
≤ 200 ppm |
EP/BP - Sulfate (SO₄) |
≤ 300 ppm |
EP/BP - Ammonium (NH₄) |
≤ 0.02 % |
EP/BP - Iron (Fe) |
≤ 10 ppm |
EP/BP - Loss on Drying |
≤ 0.5 % |
EP/BP - Ash (sulfated) |
≤ 0.1 % |
JP - Identification |
Passes Test |
JP - Optical rotation, 20° C (+) |
26.9 - 27.9 Degree |
JP - pH (1:10) |
10.5 - 12.0 |
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) |
≤ 10 ppm |
JP - Iron (Fe) |
≤ 10 ppm |
JP - Related Substances |
Passes Test |
JP - Loss on Drying at 105°C |
≤ 0.30 % |
JP - Residue after Ignition |
≤ 0.1 % |
JP - Assay (C₆H₁₄N₄O₂)(dried basis) |
98.5 - 101.0 % |
Endotoxin Concentration, IU/mg, For Information Only |
|
No Class 1,2,3 or other solvents are used or produced in the |
|
manufacturing or purification of the product. |
|
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. |
|