Description

Ticagrelor Related Compound 14 is a high-purity chemical reference standard, specifically identified as a related substance of the antiplatelet drug Ticagrelor. This compound is critical for pharmaceutical research and development, serving as a key marker for impurity profiling and method validation in quality control laboratories. It is essential for scientists and QC professionals in the pharmaceutical and analytical chemistry industries who require reliable reference materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ticagrelor active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Ticagrelor analysis.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used as a marker to track degradation products and assess the stability of Ticagrelor formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research and Development: Facilitates metabolic and pharmacokinetic studies by helping to characterize related substances and potential degradants.

Basic Information

Product Name	Ticagrelor Related Compound 14
CAS No.	2056269-94-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(1R,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; Ticagrelor Impurity 14; Ticagrelor Related Substance 14; Ticagrelor EP Impurity J; AZD6140 Related Compound 14; BRILINTA Impurity 14
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 14 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) detailing batch-specific results is provided with every shipment, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, storage at 2-8°C is recommended. The container should be kept sealed to protect from 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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