Description

Ivabradine Impurity 16 Hcl is a high-purity reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Ivabradine, a medication used to treat chronic heart failure and angina pectoris. It is primarily utilized by analytical chemists and quality assurance professionals in pharmaceutical manufacturing and contract research organizations (CROs) to ensure drug purity and safety.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ivabradine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) used in stability studies and release testing.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels remain within specified pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, helping to establish product shelf life.
• Research & Development: Aids in synthetic route optimization and impurity profiling during the drug development process.

Basic Information

Item	Detail
Product Name	Ivabradine Impurity 16 Hcl
CAS No.	304464-98-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound 16 Hydrochloride; Ivabradine Impurity 16 Hydrochloride Salt; 3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6H-cyclohepta[b]quinolin-11-yl}methyl)-1-methyl-6,7,8,9-tetrahydro-5H-pyrido[3,2-f][1,4]oxazepin-5-one Hydrochloride; (7S)-11-({5-Oxo-1-methyl-6,7,8,9-tetrahydro-5H-pyrido[3,2-f][1,4]oxazepin-3-yl}methyl)-3,4-dimethoxy-7,8,9,10-tetrahydro-6H-cyclohepta[b]quinoline Hydrochloride; Ivabradine EP Impurity 16 HCl; Ivabradine USP Impurity 16 HCl
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity 16 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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)	Complies
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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