Description

Ticagrelor Related Compound 39 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Ticagrelor by serving as a known impurity or degradation product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The material is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Ticagrelor API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and calibrating chromatographic methods to accurately identify and quantify this specific related substance.
• Stability Studies & Forced Degradation: Employed to monitor the formation of this compound during stability testing of Ticagrelor under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity profiles as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and behavior of Ticagrelor.
• Quality Assurance/Control Laboratories: Serves as a system suitability component and for routine batch analysis to ensure product purity and specification compliance.

Basic Information

Product Name	Ticagrelor Related Compound 39
CAS No.	2205903-75-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 39; Ticagrelor Related Substance 39; Ticagrelor Degradation Product; (1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino]-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (enantiomer); Ticagrelor EP Impurity K; Ticagrelor Isomer; AZD6140 Related Compound 39
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 39 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, assay, purity, and related substances. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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