Specification Test Results
GMP Manufactured Product |
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Meets U.S.P Requirements |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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USP - Assay (NH₂CONH₂) |
98.0 - 102.0 % |
USP - Identification A |
Passes Test |
USP - Identification B |
Passes Test |
USP - Residue on Ignition |
≤0.1 % |
USP - Alcohol Insoluble Matter |
≤0.04 % |
USP - Organic impurities: Urea related compound A |
≤0.1 % |
USP - Organic impurities: Any individual unspecified impurity |
≤0.1 % |
USP - Organic impurities: Total impurities |
≤2.0 % |
Solution Test |
Passes Test |
Non-Metallic Impurities - Arsenic (As), For Information Only |
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Metallic Impurities - Aluminum (Al), For Information Only |
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Metallic Impurities - Barium (Ba), For Information Only |
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Metallic Impurities - Bismuth (Bi), For Information Only |
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Metallic Impurities - Cadmium (Cd), For Information Only |
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Metallic Impurities - Calcium (Ca), For Information Only |
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Metallic Impurities - Chromium (Cr), For Information Only |
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Metallic Impurities - Cobalt (Co), For Information Only |
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Metallic Impurities - Lead (Pb), For Information Only |
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Metallic Impurities - Lithium (Li), For Information Only |
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Metallic Impurities - Magnesium (Mg), For Information Only |
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Metallic Impurities - Manganese (Mn), For Information Only |
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Metallic Impurities - Mercury (Hg), For Information Only |
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Metallic Impurities - Molybdenum (Mo), For Information Only |
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Metallic Impurities - Nickel (Ni), For Information Only |
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Metallic Impurities - Potassium (K), For Information Only |
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Metallic Impurities - Sodium (Na), For Information Only |
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Metallic Impurities - Strontium (Sr), For Information Only |
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Metallic Impurities - Vanadium (V), For Information Only |
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Metallic Impurities - Zinc (Zn), For Information Only |
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Filtered through a 0.2 micron filter. |
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Residual Solvents: No Class 1,2,3 or other solvents are used or produced |
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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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