Description

Proparacaine Impurity CAS NO 1306441-58-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the ophthalmic anesthetic, Proparacaine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Proparacaine Hydrochloride drug substance and finished ophthalmic solutions.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating stability-indicating assay methods for Proparacaine, ensuring accurate detection limits.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing of active pharmaceutical ingredients (APIs) to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Essential for generating regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions (heat, light, humidity) as part of drug stability programs.
• Research & Development: Facilitates research into the degradation pathways and pharmacokinetics of Proparacaine.

Basic Information

Item	Detail
Product Name	Proparacaine Impurity
CAS No.	1306441-58-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Proparacaine Related Compound; Proparacaine Degradant; Proparacaine Process Impurity; 3-Amino-4-propoxybenzoic acid 2-(diethylamino)ethyl ester impurity; Alcaine Impurity; Ophthalne Impurity; Proxymetacaine Impurity
EINECS	Contact for details

Quality Control

Our Proparacaine Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A/B guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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