Description

Alcaftadine Impurity 5 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Alcaftadine, an antihistamine used in ophthalmic solutions. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Alcaftadine API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Batch Release: Essential for routine testing of Alcaftadine batches to ensure they meet the specified impurity limits as per ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of degradation products in Alcaftadine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Alcaftadine.

Basic Information

Item	Detail
Product Name	Alcaftadine Impurity 5
CAS No.	147083-92-9
Molecular Formula	C19H21N3O
Molecular Weight	307.39 g/mol
Synonyms	11-(3-Methyl-4-piperidinylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Alcaftadine Related Compound; Alcaftadine Process Impurity; Alcaftadine Degradant; (Z)-11-(3-Methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; UNII-5Q4K4V7F0F; Alcaftadine Impurity F (may be designated as); Alcaftadine EP Impurity
EINECS	Contact for details

Quality Control

Every batch of Alcaftadine Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and strength, compliant with current pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. Our commitment to traceability and data integrity supports your regulatory and quality assurance requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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