Description

Ticagrelor Impurity N is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiplatelet drug Ticagrelor during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Ticagrelor Impurity N in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling of Ticagrelor.
• Quality Control & Assurance (QC/QA): Essential for routine impurity testing to ensure Ticagrelor drug substances and products meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Ticagrelor formulations under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the FDA and EMA.
• Research & Development: Used in R&D to study the degradation pathways, metabolism, and pharmacokinetics of Ticagrelor.

Basic Information

Product Name	Ticagrelor Impurity N
CAS No.	1643378-47-5
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 Related Compound N; Ticagrelor Impurity 12; Ticagrelor EP Impurity N; Ticagrelor USP Impurity N; AZD6140 Impurity N; Brilinta Impurity N
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity N is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Our products are characterized using advanced techniques including HPLC, MS, and NMR to meet the exacting standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectral confirmation is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment and handled with appropriate personal protective equipment in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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