Description

Ivabradine Impurity 21 Hcl is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Ivabradine, a medication used to treat chronic heart failure and angina pectoris. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and efficacy. The availability of this well-characterized impurity is essential for method validation and meeting stringent regulatory compliance standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ivabradine Impurity 21 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Ivabradine drug substances and products comply with pharmacopeial limits (e.g., ICH Q3A/B, USP, EP) for related substances.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and impurity profiling studies during the development of Ivabradine and its generic versions.

Basic Information

Product Name	Ivabradine Impurity 21 Hcl
CAS No.	304465-03-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound 21 Hydrochloride; Ivabradine EP Impurity 21 HCl; Ivabradine USP Impurity 21 Hydrochloride; (7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-amine Hydrochloride (partial structure); S 16257-21 Impurity; Procoralan Impurity 21 HCl; Coralan Impurity 21 Hydrochloride; Corlentor Impurity 21 HCl
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Ivabradine Impurity 21 Hcl is characterized using advanced analytical techniques, including HPLC, LC-MS, NMR, and IR spectroscopy, to confirm identity and purity. We adhere to current Good Manufacturing Practices (cGMP) principles for pharmaceutical reference standards. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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