Description

Ivabradine Impurity 70 is a designated pharmaceutical reference standard used for the analytical profiling and quality control of Ivabradine, a selective sinus node inhibitor. This impurity is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ivabradine Impurity 70 in Ivabradine API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Used as a critical component for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Quality Control & Batch Release Testing: Essential for in-house QC laboratories to confirm that Ivabradine batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research and Development: Used in R&D to understand the degradation pathways and chemistry of Ivabradine, aiding in process optimization and impurity control strategies.

Basic Information

Product Name	Ivabradine Impurity 70
CAS No.	79623-31-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound 70; Ivabradine Impurity D (Potential Designation); 3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methano[1,2]azacycloundecino[5,4-b]indol-7(6H)-yl}methyl)-1,3-oxazolidin-2-one; S 16257 Impurity; Procoralan Impurity; Coralan Impurity; (7S)-7-{[(2-Oxo-1,3-oxazolidin-3-yl)methyl]}-10,11-dimethoxy-1,2,3,4,6,7,8,9,10,11-decahydro-7,10-epiminocycloocta[b]indole
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity 70 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

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 Certificate of Analysis. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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