Description

Ticagrelor Impurity 27 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Ticagrelor. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on cardiovascular drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control (QC) testing of Ticagrelor active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Research & Development: Used in HPLC, UPLC, and LC-MS studies to establish impurity profiles, degradation pathways, and stability-indicating methods for Ticagrelor.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Process Chemistry & Optimization: Helps chemists identify and minimize the formation of this impurity during the synthesis and purification stages of Ticagrelor manufacturing.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Ticagrelor Impurity 27
CAS No.	1402150-01-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 27; Ticagrelor Impurity 27 (1402150-01-9); Ticagrelor EP Impurity G; Ticagrelor USP 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 (Potential IUPAC); AZD6140 Impurity 27; Brilinta Impurity 27
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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