Description

Alcaftadine Impurity 4 CAS NO 147083-12-3 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 active pharmaceutical ingredient (API) Alcaftadine, an antihistamine used in ophthalmic solutions. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, impurity profiling, and stability studies. The availability of this well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and supporting new drug applications.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Impurity 4 in Alcaftadine API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches comply with specified impurity limits (e.g., ICH guidelines).
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop purification processes for the main API.

Basic Information

Product Name	Alcaftadine Impurity 4
CAS No.	147083-12-3
Molecular Formula	C19H21N3O2
Molecular Weight	323.39 g/mol
Synonyms	6,11-Dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde; Alcaftadine Related Compound D; Alcaftadine Aldehyde Impurity; (11Z)-6,11-Dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde; UNII-4B4I6Q6J8W; Alcaftadine Process Impurity; Alcaftadine Degradant
EINECS	Contact for details

Quality Control

Every batch of Alcaftadine Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with ICH Q3A/B guidelines for impurities in new drug substances and products. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic techniques. Our quality commitment supports compliance with cGMP standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive); therefore, the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm

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