Résultats des tests de spécification
GMP Manufactured Product |
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Meets B.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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Meets J.P. Chemical Specifications |
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Meets U.S.P Requirements |
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Store in well-closed,light-resistant containers |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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USP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis) |
98.5 - 101.5 % |
USP - Identification |
Passes Test |
USP - Specific Rotation [Å]²º^D (+) |
21.4 - 23.6 Degree |
USP - Loss on Drying at 105°C |
≤ 0.2 % |
USP - Residue on Ignition |
≤ 0.1 % |
USP - Sulfate (SO₄) |
≤ 0.03 % |
USP - Related Compounds - Individual Impurities |
≤ 0.5 % |
USP - Related Compounds - Total Impurities |
≤ 2.0 % |
USP - Chloride (Cl) |
16.5 - 17.1 % |
FCC - Assay (C₆H₁₄N₄O₂·HCl) (dried basis) |
98.5 - 101.5 % |
FCC - Identification |
Passes Test |
FCC - Loss on Drying |
≤ 0.3 % |
FCC - Residue after Ignition |
≤ 0.10 % |
FCC - Specific Rotation [Å]²º^D (+) |
21.3 - 23.5 Degree |
FCC - Lead (Pb) |
≤ 5 mg/kg |
EP/BP - Assay (C₆H₁₄N₄O₂·HCl) (dried basis) |
98.5 - 101.0 % |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification B |
Passes Test |
EP/BP - Identification E |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Specific Rotation [Å]²º^D (+) |
21.0 - 23.5 Degree |
EP/BP-Ninhydrin-Positive Substances-Each |
≤ 0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities |
≤ 0.5 % |
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 - Assay (C₆H₁₄N₄O₂·HCl) (dried basis) |
98.5 - 101.0 % |
JP - Identification |
Passes Test |
JP - Optical Rotation (+) |
21.5 - 23.5 Degree |
JP - pH (1 in 10) |
4.7 - 6.2 |
JP - Clarity and Color of Solution |
Passes Test |
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 |
≤ 0.20 % |
JP - Residue after Ignition |
≤ 0.10 % |
Endotoxin Concentration, IU/mg, For Information Only |
≤ 20 ppm |
No Class 1,2,3 or other solvents are used or produced in the |
≤ 2 ppm |
manufacturing or purification of the product. |
Passes Test |
Elemental Impurities (USP (232), EP 5.20) - Information on elemental |
≤ 0.10 % |
impurities for this product is available on the associated Product |
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Regulatory Data Sheet and elemental impurity profile report. |
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