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CAUTION: For Manufacturing, processing or repackaging
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Bulk Pharmaceutical Chemical
Passes Test
NF - Identification A
Passes Test
NF - Identification B
Passes Test
NF - Specific Gravity at 25°/25°C
≤0.789
NF - Nonvolatile Residue
≤0.004 %
NF - Readily Oxidizable Substances
Passes Test
NF - Water (H₂O)
≤0.5 %
NF - Assay (as (CH₃)₂CO) (calculated on anhydrous basis)
99.5 - 100.5 %
NF - Benzene
≤2 ppm
EP/BP - Identification A
Passes Test
EP/BP - Identification B
Passes Test
EP/BP - Identification C
Passes Test
EP/BP - Appearance of Solution
Passes Test
EP/BP - Acidity or Alkalinity
Passes Test
EP/BP - Density (g/mL) at 20°C
0.790 - 0.793
EP/BP - Related Substances - Impurity A
≤0.05 %
EP/BP - Related Substances - Impurity B
≤0.05 %
EP/BP - Related Substances - Impurity C
≤2 ppm
EP/BP- Other Impurities
≤0.05 %
EP/BP - Matter Insoluble in H₂O
Passes Test
EP/BP - Reducing Substances
Passes Test
EP/BP - Residue after Evaporation
≤50 ppm
EP/BP - Water (H₂O), g/L
≤3 g/l
Class 1, 2 and 3 residual solvents are likely to be present. Benzene (Class 1) is reported on each lot and is below the USP/NF limit concentration. Methanol and Toluene (Class 2) are both below their
Option 1 limits. All Class 3 solvents are <0.5%.
Elemental Impurities (USP (232), EP 5.20) - Information on elemental
impurities for this product is available on the associated Product
Regulatory Data Sheet and elemental impurity profile report.