Description

Phenylbutazone is a non-steroidal anti-inflammatory drug (NSAID) of the pyrazolidine class, widely recognized for its potent analgesic and antipyretic properties. This compound is a critical active pharmaceutical ingredient (API) for the formulation of veterinary and, in some regions, human medicinal products. It is essential for manufacturers in the pharmaceutical industry requiring a reliable, high-purity bulk chemical for the production of anti-inflammatory treatments. Phenylbutazone CAS NO 4297-92-1 is supplied to meet the stringent demands of GMP-compliant production facilities globally.

Application

• Veterinary Pharmaceuticals: Primary use as an anti-inflammatory and analgesic agent for the treatment of musculoskeletal disorders in horses and other large animals.
• Human Pharmaceutical Intermediates: Serves as a key starting material or intermediate in the synthesis of more advanced NSAID derivatives for human use in specific markets.
• Research & Development: Utilized in biochemical and pharmacological research to study inflammation pathways, COX enzyme inhibition, and drug metabolism.
• Bulk API Manufacturing: Supplied to certified contract manufacturing organizations (CMOs) for the production of finished dosage forms such as tablets, injectables, and pastes.
• Reference Standard: High-purity grades are used as a certified reference material (CRM) in analytical laboratories for quality control and method validation.

Basic Information

Product Name	Phenylbutazone
CAS No.	4297-92-1
Molecular Formula	C19H20N2O2
Molecular Weight	308.38 g/mol
Synonyms	4-Butyl-1,2-diphenyl-3,5-pyrazolidinedione; Butazolidin; Butadion; Diphenylbutazone; Fenilbutazona; 1,2-Diphenyl-4-butyl-3,5-pyrazolidinedione; PBZ; Bute
EINECS	224-309-6

Quality Control

Our Phenylbutazone is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications, with specifications aligning with major pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, assay, purity, and related substances. We support compliance with cGMP, ICH Q7, and relevant regulatory frameworks (e.g., FDA, EMA) for active pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (Karl Fischer)	≤ 0.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.