Description

Olopatadine Impurity 29 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Olopatadine, an active pharmaceutical ingredient (API) used in anti-allergic medications. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Olopatadine API and finished drug products.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiles and data for drug master files (DMFs).
• Stability Studies: Used to monitor impurity formation and degradation pathways during forced degradation and long-term stability studies of Olopatadine.
• Process Chemistry Research: Aids in the identification and control of process-related impurities during the synthesis and purification of Olopatadine.
• Quality Assurance/Control (QA/QC): Employed as a system suitability and calibration standard to ensure the accuracy and precision of analytical instrumentation.

Basic Information

Product Name	Olopatadine Impurity 29
CAS No.	949141-21-3
Molecular Formula	C21H23NO3
Molecular Weight	337.42 g/mol
Synonyms	11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid; (Z)-2-[11-[3-(Dimethylamino)propylidene]-6H-dibenzo[b,e]oxepin-2-yl]acetic acid; Olopatadine Related Compound 29; Olopatadine EP Impurity K; Olopatadine USP Impurity; ALE-29; UNII-9K5P8V6F0T
EINECS	Contact for details

Quality Control

Every batch of Olopatadine Impurity 29 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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