Description

Articaine Impurity G (Butylarticaine Hcl) is a high-purity chemical reference standard, specifically identified as a process-related impurity of the local anesthetic Articaine. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring drug purity, safety, and regulatory compliance. It is primarily required by analytical laboratories, quality control units, and R&D departments within the pharmaceutical industry for method development, validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Butylarticaine in Articaine hydrochloride drug substance and finished products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring final product safety and efficacy.
• Stability Studies: Acts as a reference point in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate comprehensive impurity control.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and optimize manufacturing processes to minimize this impurity.

Basic Information

Product Name	Articaine Impurity G (Butylarticaine Hcl)
CAS No.	23964-59-2
Molecular Formula	C15H23N3O3S • HCl
Molecular Weight	361.89 g/mol (Free base: 325.43 g/mol)
Synonyms	Butylarticaine Hydrochloride; 4-Methyl-3-[[2-(propylamino)butanoyl]amino]-2-thiophenecarboxylic acid methyl ester hydrochloride; Articaine EP Impurity G; Articaine USP Impurity G; Articaine Related Compound G; Carticaine Impurity G; (±)-Butylarticaine HCl; 4-Methyl-3-[(1-oxo-2-(propylamino)butyl)amino]-2-thiophenecarboxylic acid methyl ester hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Articaine Impurity G is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (IR, NMR, MS) techniques to ensure compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 1.0%
Water Content (KF)	≤ 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.