Description

Butalbital Impurity 1 (CAS NO 53943-65-0) is a designated analytical reference standard used for the identification and quantification of process-related impurities in the active pharmaceutical ingredient (API) Butalbital. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations containing Butalbital. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, method development, and compliance testing.

Application

• Pharmaceutical Quality Control (QC): Serves as a certified reference material for the identification and quantification of Butalbital Impurity 1 in drug substance and finished product testing.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various stress conditions to establish product shelf-life.
• Regulatory Compliance and Submissions: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate control over the impurity profile.
• Research and Development (R&D): Used in process chemistry R&D to understand and minimize the formation of this impurity during Butalbital synthesis.
• Pharmacopoeial Testing: Supports testing in accordance with pharmacopoeial monographs (e.g., USP, EP) that specify impurity limits for Butalbital.

Basic Information

Item	Detail
Product Name	Butalbital Impurity 1
CAS No.	53943-65-0
Molecular Formula	C11H16N2O3
Molecular Weight	224.26 g/mol
Synonyms	5-Allyl-5-isobutylbarbituric acid; 5-Allyl-5-(2-methylpropyl)-2,4,6(1H,3H,5H)-pyrimidinetrione; 5-Allyl-5-isobutylbarbituric acid impurity; Butalbital Related Compound A; Butalbital Process Impurity; 1,3-Diazinane-2,4,6-trione, 5-allyl-5-(2-methylpropyl)-; Barbituric acid, 5-allyl-5-isobutyl-
EINECS	Contact for details

Quality Control

Our Butalbital Impurity 1 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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