Description

Ticagrelor Related Compound 3 is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Ticagrelor, a key antiplatelet medication, by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality control processes.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material 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 and validating HPLC, UPLC, and other chromatographic methods for purity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to monitor impurity levels and ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of degradation products in Ticagrelor formulations under various storage conditions.
• Research and Development: Facilitates studies on the metabolism, pharmacokinetics, and degradation pathways of Ticagrelor.

Basic Information

Product Name	Ticagrelor Related Compound 3
CAS No.	88756-83-6
Molecular Formula	C23H28F2N6O4S
Molecular Weight	522.57 g/mol
Synonyms	(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; Ticagrelor Impurity 3; Ticagrelor Related Substance 3; Ticagrelor EP Impurity C; BRILINTA Impurity 3; AZD6140 Related Compound 3
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 3 is manufactured under strict quality systems and undergoes comprehensive analytical testing to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is characterized using advanced techniques including NMR, MS, and HPLC to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing results against specifications aligned with ICH Q3A/B, USP, and EP guidelines.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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