
Chemical Name: 4-Butyl-1,2-diphenyl-3,5-pyrazolidinedione
Chemical Formula: C19H20N2O2
Molecular Weight: 312.37 g/mol
Structure: It is a pyrazolidinedione derivative with two phenyl groups and a butyl side chain.
Appearance: White or almost white crystalline powder or crystals.
Solubility: Slightly soluble in water, soluble in alcohol, chloroform, and ether.
Identification Tests: IR spectrum, UV spectrum, and specific chemical reactions confirm identity.
Assay: Typically uses titration or chromatographic methods (HPLC) to determine purity and content. Should contain not less than 98.0% and not more than 102.0% of C19H20N2O2.
Related Substances: Limits on impurities and degradation products defined. Uses chromatography (e.g., HPLC) for quantification.
Loss on Drying: Usually less than 0.5%, ensuring minimal moisture content.
Residue on Ignition: Usually less than 0.1%.
Heavy Metals: Controlled to a defined low limit.
Microbial Limits: Specified to ensure product safety.
Similar to BP in identification methods and purity requirements.
Assay: May specify HPLC method with defined mobile phase, column type, and detection wavelength.
Impurities: Lists specific known impurities with maximum allowable limits.
Physical Properties: Melting point usually ranges from 97 C to 103 C.
Other Tests: Tests for heavy metals, residual solvents, and microbial contamination.
Identification: IR spectrum, UV absorbance, and chromatographic profile.
Assay: Typically by HPLC or titration. Assay range usually between 98.0% and 102.0%.
Impurities: Limits on known impurities and degradation products.
Physical Properties: White crystalline powder, melting point around 97-103 C.
Microbial Limits: USP sets limits for non-sterile products.
Phenylbutazone is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties.
It works by inhibiting cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis.
Store in a well-closed container, protected from light and moisture.
Stable under normal conditions but sensitive to prolonged exposure to air and light.
Historically used to treat inflammatory conditions such as arthritis and gout.
Due to side effects, its use in humans has declined but it is still used in veterinary medicine.
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