Specification Test Results
GMP Manufactured Product |
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Meets U.S.P Requirements |
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Meets B.P. Chemical Specifications |
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Meets ChP Chemical Specifications |
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Meets E.P. Chemical Specifications |
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Meets J.P. Chemical Specifications |
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Store in airtight container. |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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USP - Assay (C₆H₉N₃O₂) (dried basis) |
98.5 - 101.5 % |
USP - Identification |
Passes Test |
USP - Specific Rotation [Å]²⁵ D (+) |
12.6 - 14.0 Degree |
USP - pH |
7.0 - 8.5 |
USP - Loss on Drying at 105°C |
≤ 0.2 % |
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 % |
EP/BP - Assay (C₆H₉N₃O₂) (dried basis) |
98.5 - 101.0 % |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification B |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Specific Rotation [Å]²ºD (+) |
11.4 - 12.4 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 - Assay (C6H9N3O2) (dried basis) |
99.0 - 101.0 % |
JP - Ammonium (NH₄) |
≤ 0.02 % |
JP - Chloride (Cl) |
≤ 0.021 % |
JP - Clarity and Color of Solution |
Passes Test |
JP - Heavy Metals (as Pb) |
≤ 10 ppm |
JP - Iron (Fe) |
≤ 10 ppm |
JP - Identification |
Passes Test |
JP - Loss on Drying at 105°C |
≤ 0.30 % |
JP- Optical Rotation [Å]²ºD (+) |
11.8 - 12.8 Degree |
JP - Related Substances |
Passes Test |
JP - pH |
7.0 - 8.5 |
JP - Residue on Ignition |
≤ 0.10 % |
JP - Sulfate (SO₄) |
≤ 0.028 % |
ChP - Assay (dried basis) |
99.0 - 101.0 % |
ChP -Specific Rotation @ 20 °C (+) |
12.0 - 12.8 Degree |
ChP - Identification 1 (TLC) |
Passes Test |
ChP - Identification 2 (IR) |
Passes Test |
ChP - Acidity or alkalinity (pH) |
7.0 - 8.5 |
ChP - Transmittance of solution |
≥ 98.0 % |
ChP - Chlorides |
≤ 0.02 % |
ChP - Sulfates |
≤ 0.02 % |
ChP - Ammonium |
≤ 0.02 % |
ChP - Other amino acids (TLC)(<lt/≥0.5%, one spot only) |
Passes Test |
ChP - Loss on drying @ 105 °C |
≤ 0.2 % |
ChP - Residue on ignition |
≤ 0.1 % |
ChP - Iron |
≤ 0.001 % |
ChP - Heavy metals |
≤ 0.001 % |
ChP - Arsenic |
≤ 0.0001 % |
ChP - Bacterial endotoxin, EU/g |
≤ 6.0 |
No Class 1,2,3 or other solvents are used or produced in the |
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manufacturing or purification of the product. |
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Elemental Impurities (USP (232), EP 5.20) - Information on elemental |
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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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