Description

Articaine Impurity A CAS NO 1712677-79-6 is a specified impurity of Articaine Hydrochloride, a local anesthetic widely used in dental procedures. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in the synthesis, purification, and regulatory compliance of Articaine API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating methods in impurity profiling.
• Method Development and Validation: Used in developing and validating HPLC, UPLC, or GC methods for the precise quantification of Articaine Impurity A.
• Quality Control and Batch Release: Critical for ensuring the purity and safety of Articaine Hydrochloride Active Pharmaceutical Ingredient (API) by setting and verifying specification limits.
• Stability Studies: Employed to track the formation and growth of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Articaine to minimize the formation of this specific impurity.

Basic Information

Product Name	Articaine Impurity A
CAS No.	1712677-79-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Articaine Related Compound A; Articaine EP Impurity A; Articaine USP Impurity A; 4-Methyl-3-[[2-(propylamino)propanoyl]amino]thiophene-2-carboxylic acid methyl ester (probable structure based on naming conventions); Articaine Process Impurity; Articaine Degradant
EINECS	Contact for details

Quality Control

Every batch of Articaine Impurity A is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with relevant specifications.

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) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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