Description

Ticagrelor Related Compound 19 is a high-purity chemical reference standard, identified by CAS NO 2378409-07-3. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Ticagrelor, a key antiplatelet medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and stringent quality control processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Ticagrelor bulk drug and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in GMP environments to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in Ticagrelor formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Ticagrelor.

Basic Information

Product Name	Ticagrelor Related Compound 19
CAS No.	2378409-07-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 19; Ticagrelor Related Substance 19; Ticagrelor EP Impurity J; Ticagrelor USP Related Compound 19; (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; AZD6140 Related Compound 19; Brilinta Impurity 19
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 19 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 accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, typically assessed by HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.