Description

Ivabradine Impurity S33172 is a designated impurity standard used in the pharmaceutical development and quality control of Ivabradine, a selective sinus node inhibitor. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of S33172 in Ivabradine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor this specific impurity.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Ivabradine batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Stability Studies: Used to track the formation and level of S33172 over time under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Ivabradine Impurity S33172
CAS No.	2247881-26-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	S33172; Ivabradine Related Compound S33172; Ivabradine Impurity 9; Ivabradine EP Impurity G; Ivabradine Process Impurity; 3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methanocyclohepta[b]quinolin-11(6H)-yl}methyl)-1-methyl-1,8-naphthyridin-2(1H)-one; (7S)-11-({1-Methyl-2-oxo-1,2-dihydro-1,8-naphthyridin-3-yl}methyl)-6,7,8,9,10,11-hexahydro-3,4-dimethoxy-6,9-methanocyclohepta[b]quinoline
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity S33172 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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