Description

Ticagrelor Related Compound 38D-Tartrate is a high-purity chemical reference standard, specifically a tartrate salt of a key related substance of the antiplatelet drug Ticagrelor. This compound is critical for pharmaceutical research, development, and quality control, serving as an essential benchmark for the identification and quantification of impurities in Ticagrelor active pharmaceutical ingredients (APIs) and finished drug products. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in pharmaceutical companies and contract research organizations (CROs) to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Ticagrelor-related impurities during method development and validation.
• Analytical Method Development: Serves as a critical standard for developing and optimizing HPLC, UPLC, or LC-MS methods for Ticagrelor API and formulation analysis.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels in Ticagrelor batches, ensuring they meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradant in Ticagrelor drug substances and products under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to characterize and justify impurity limits in new drug applications (NDAs).
• Research and Development: Facilitates studies on the metabolism, degradation pathways, and synthesis process optimization of Ticagrelor.

Basic Information

Product Name	Ticagrelor Related Compound 38D-Tartrate
CAS No.	2165881-71-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 38D Tartrate; Ticagrelor Related Substance 38D Tartrate Salt; (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 Tartrate; Ticagrelor EP Impurity D Tartrate; Ticagrelor USP Related Compound D Tartrate; BRILINTA Related Compound 38D Tartrate; AZD6140 Related Compound 38D Tartrate
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 38D-Tartrate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) detailing purity, impurity profile, and structural confirmation data, supporting compliance with ICH, USP, and EP guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

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)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.