Description

Ticagrelor Impurity CAS NO 1882095-51-3 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the antiplatelet drug Ticagrelor by serving as a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the calibration of analytical instruments in QC/QA labs.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods for Ticagrelor analysis.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity in Ticagrelor drug substance and product over time.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and improve manufacturing processes.
• Pharmacopoeial Testing: Applicable for testing against monographs in pharmacopoeias like USP, EP, or BP where this impurity is specified.

Basic Information

Product Name	Ticagrelor Impurity
CAS No.	1882095-51-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound; Ticagrelor Impurity Standard; Ticagrelor Process Impurity; (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); AZD6140 Impurity; Brilinta Impurity; AR-C126532XX Impurity
EINECS	Contact for details

Quality Control

Our Ticagrelor Impurity is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A Certificate of Analysis (COA) detailing batch-specific results is provided, ensuring traceability and compliance with ICH guidelines Q3A(R2) and Q3B(R2) for impurities.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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