Description

3-Hydroxyphenobarbital is a key pharmaceutical intermediate and metabolite of the barbiturate class. This compound is critical for analytical research, method development, and quality control in the pharmaceutical and forensic science industries. It is primarily utilized by research institutions, pharmaceutical manufacturers, and contract testing laboratories for applications such as reference standards, metabolite studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of phenobarbital and its metabolites in drug substances and products.
• Metabolite Studies: Serves as a critical standard in pharmacokinetic and pharmacodynamic research to study the metabolism, distribution, and excretion of phenobarbital.
• Impurity Profiling: Employed in the identification and quantification of related substances and degradation products during the stability testing and quality control of barbiturate-based APIs.
• Forensic & Clinical Toxicology: Acts as a calibration standard in analytical methods (HPLC, LC-MS/MS, GC-MS) for the detection and confirmation of barbiturates in biological matrices.
• Method Development & Validation: Essential for developing, optimizing, and validating chromatographic and spectroscopic analytical methods in compliance with ICH and pharmacopeial guidelines.
• Biochemical Research: Used in studies investigating the enzymatic pathways involved in drug metabolism, particularly cytochrome P450 activities.

Basic Information

Product Name	3-Hydroxyphenobarbital
CAS No.	427-17-8
Molecular Formula	C12H12N2O4
Molecular Weight	248.24 g/mol
Synonyms	5-Ethyl-5-(3-hydroxyphenyl)-2,4,6(1H,3H,5H)-pyrimidinetrione; 3'-Hydroxyphenobarbital; Phenobarbital 3'-hydroxy metabolite; 5-(3-Hydroxyphenyl)-5-ethylbarbituric acid; NSC 163044; 1H,3H,5H-Pyrimidinetrione, 5-ethyl-5-(3-hydroxyphenyl)-; 5-Ethyl-5-(m-hydroxyphenyl)barbituric acid
EINECS	Contact for details

Quality Control

Our 3-Hydroxyphenobarbital is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification by IR and NMR, purity assay by HPLC, and control of specified impurities, to ensure it meets high-purity standards suitable for research and analytical applications. A comprehensive Certificate of Analysis (COA) detailing all test results and methods is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%

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