Specification Test Results
Meets E.P. Chemical Specifications |
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Meets B.P. Chemical Specifications |
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GMP Manufactured Product |
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Meets N.F. Requirements |
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Store in well-closed,light-resistant containers |
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Preserve in well-closed containers. |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
For Information Only |
NF - Assay (dried basis) |
98.0 - 101.5 % |
NF - Identification A |
Passes Test |
NF - Identification B |
Passes Test |
NF - Specific Rotation @ 20 °C (+) |
33.0 - 36.5 Degree |
NF - Loss on Drying at 130°C |
11.5 - 12.5 % |
NF - Residue on Ignition |
≤ 0.1 % |
NF - Chromatographic Purity: Asparagine related compound A |
≤ 1.0 % |
NF - Chromatographic Purity: Aspartic acid |
≤ 1.0 % |
NF - Chromatographic Purity: Each individual unidentified impurity |
≤ 0.5 % |
NF - Chromatographic Purity: Total impurities |
≤ 3.0 % |
NF - Lead (Pb) |
≤ 5 ppm |
NF - Total Aerobic Microbial Count, cfu/g |
≤ 1000 |
NF - Total Yeast and Mold Count, cfu/g |
≤ 100 |
EP/BP - Assay (dried basis) |
99.0 - 101.0 % |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification B |
Passes Test |
EP/BP - Identification D |
Passes Test |
EP/BP - Appearance of Solution |
Passes Test |
EP/BP - Specific Rotation @ 20 °C (+) |
33.7 - 36.0 Degree |
EP/BP - Chloride (Cl) |
≤ 200 ppm |
EP/BP - Sulfate (SO₄) |
≤ 200 ppm |
EP/BP - Ammonium (NH₄) |
≤ 0.1 % |
EP/BP - Iron (Fe) |
≤ 10 ppm |
EP/BP - Loss on Drying at 130° C |
10.5 - 12.5 % |
EP/BP - Sulfated Ash |
≤ 0.1 % |
EP/BP - pH |
4.0 - 6.0 |
EP/BP - Related Substances - Impurity A |
≤ 0.5 % |
EP/BP - Related Substances - Impurity C |
≤ 0.1 % |
EP/BP - Related Substances - Unspecified impurities, each |
≤ 0.05 % |
EP/BP - Related Substances - Total impurities |
≤ 0.8 % |
Endotoxin Concentration, IU/mg, For Information Only |
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Residual solvents: Only the Class 2 solvent methanol is likely to be |
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present from use in the manufacturing process. Methanol content is |
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controlled to <200 ppm as a manufacturing process limit. |
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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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