Description

Olopatadine-D3 n-Oxide is a deuterated derivative of the active pharmaceutical ingredient Olopatadine, specifically labeled at three positions with deuterium and oxidized at the nitrogen atom. This compound is a critical reference standard and stable isotope-labeled internal standard used in advanced analytical chemistry for precise quantification and metabolic studies. It is essential for researchers and quality control laboratories in the pharmaceutical and biotechnology sectors who require high-fidelity analytical tools. The compound enables accurate mass spectrometry and chromatographic analysis, ensuring data integrity in method development and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used for the identification, purity assessment, and quantification of Olopatadine and its metabolites in drug substances and products.
• Mass Spectrometry Internal Standard: Serves as a critical stable isotope-labeled internal standard (SIL-IS) in LC-MS/MS and GC-MS bioanalytical methods for precise pharmacokinetic and bioequivalence studies.
• Metabolic Pathway Research: Facilitates the study of drug metabolism and disposition (DMPK) by tracing deuterium labels in in vitro and in vivo systems.
• Method Development and Validation: A key component in developing and validating robust analytical methods compliant with ICH, FDA, and EMA guidelines.
• Impurity Profiling: Aids in the characterization and control of process-related impurities and degradation products in pharmaceutical manufacturing.
• Clinical Research: Supports clinical trial analysis by providing accurate measurement of drug concentrations in biological matrices.

Basic Information

Product Name	Olopatadine-D3 n-Oxide
CAS No.	1246832-94-9
Molecular Formula	C21H20D3NO3
Molecular Weight	340.44 g/mol (Calculated)
Synonyms	11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid-D3 N-Oxide; (11Z)-11-(3-(Dimethylamino)propylidene)-6,11-dihydrodibenz[b,e]oxepin-2-acetic Acid-d3 N-Oxide; Olopatadine N-Oxide-d3; Deuterated Olopatadine N-Oxide; Olopatadine-d3 N-Oxide; KW-4679-d3 N-Oxide; (Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic Acid-d3 N-Oxide
EINECS	Contact for details

Quality Control

Every batch of Olopatadine-D3 n-Oxide is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a high-purity reference material. Certificates of Analysis (COA) are supplied with each shipment, detailing critical parameters such as isotopic purity, chemical purity, and identity confirmation via advanced spectroscopic techniques. Our quality protocols are designed to meet the stringent requirements of pharmaceutical R&D and regulatory compliance.

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 product 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 reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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