Specification Test Results
GMP Manufactured Product |
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Meets J.P. Chemical Specifications |
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Meets E.P. Chemical Specifications |
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Meets U.S.P Requirements |
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Preserve in well-closed containers. |
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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 (C₁₁H₁₂N₂O₂) (dried basis) |
98.5 - 101.5 % |
USP - Identification |
Passes Test |
USP - Specific Rotation [Å]²⁵ ^D |
-32.8 - -29.4 Degree |
USP - pH |
5.5 - 7.0 |
USP - Loss on Drying at 105°C |
≤0.3 % |
USP - Residue on Ignition |
≤0.1 % |
USP - Chloride (Cl) |
≤0.05 % |
USP - Sulfate (SO₄) |
≤0.03 % |
USP - Iron (Fe) |
≤0.003 % |
USP - Organic Impurities - Total Impurities 1 |
≤0.01 % |
USP - Organic Impurities - Total Impurities 2 |
≤0.03 % |
USP - Organic Impurities - Tryptophan Related Compound A |
≤10 ppm |
JP - Assay (C₁₁H₁₂N₂O₂) (dried basis) |
98.5 - 101.0 % |
JP - Identification |
Passes Test |
JP - Specific Rotation [Å]²º^D |
-33.0 - -30.0 Degree |
JP - pH |
5.4 - 6.4 |
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 on Ignition |
≤0.10 % |
Endotoxin Concentration, IU/mg, For Information Only |
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EP - Identification A |
Passes Test |
EP - Identification B |
Passes Test |
EP - Appearance of Solution |
Passes Test |
EP - Specific Optical Rotation [Å]²º^D |
-33.0 - -30.0 Degree |
EP/BP-Ninhydrin-Positive Substances-Each |
≤0.2 % |
EP/BP-Ninhydrin-Positive Substances-Total Impurities |
≤0.5 % |
EP - 1,1'Ethylidenebistryptophan |
≤10 ppm |
EP - Sum of the Areas less than Tryptophan® |
≤100 ppm |
EP - Sum of the Areas greater than Tryptophan® |
≤300 ppm |
EP - Chloride (Cl) |
≤200 ppm |
EP - Sulfate (SO₄) |
≤300 ppm |
EP/BP - Ammonium (NH₄) |
≤0.02 % |
EP - Iron (Fe) |
≤20 ppm |
EP - Loss on Drying at 105°C |
≤0.5 % |
EP - Sulfated Ash |
≤0.1 % |
EP - Assay (C₁₁H₁₂N₂O₂) (dried basis) |
98.5 - 101.0 % |
Only Class 2 Solvents (Methanol) are likely to be present. All are |
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below Option 1 limits. |
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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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