Description

Olopatadine-D3 Hydrochloride is a deuterated isotopologue of the potent antihistamine and mast cell stabilizer, olopatadine hydrochloride, where three hydrogen atoms are replaced by deuterium. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the development and quality control of ophthalmic and anti-allergy medications.

Application

• Internal Standard for LC-MS/MS Analysis: Primary application as a high-purity reference standard for the precise quantification of olopatadine in biological matrices (plasma, serum, tears).
• Pharmacokinetic and Bioavailability Studies: Enables accurate measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of olopatadine metabolites in complex samples.
• Method Development and Validation: Serves as a critical component in developing and validating robust, regulatory-compliant bioanalytical assays.
• Drug Impurity and Degradation Pathway Analysis: Used in stability-indicating methods to track and quantify drug-related substances.
• Clinical Trial Support: Provides the analytical foundation for reliable data generation in human and animal clinical trials.

Basic Information

Product Name	Olopatadine-D3 Hydrochloride
CAS No.	1217229-05-4
Molecular Formula	C21H20D3ClNO3 • HCl
Molecular Weight	408.36 g/mol (approx.)
Synonyms	11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid-D3 hydrochloride; (Z)-11-(3-(Dimethylamino)propylidene)-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid-D3 HCl; KW-4679-D3 hydrochloride; Deuterated Olopatadine HCl; Olopatadine (methyl-d3) Hydrochloride; Stable Isotope Labeled Olopatadine HCl
EINECS	Contact for details

Quality Control

Our Olopatadine-D3 Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR (¹H, ²H, ¹³C) for isotopic enrichment verification and HPLC for chemical and isotopic purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, isotopic enrichment, residual solvents, and other critical parameters to support your regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0% (chemical purity)
Isotopic Enrichment (²H NMR)	≥ 98.0 atom % D
Isotopic Purity (LC-MS)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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