Description

Isoquinoline Impurity 19 CAS NO 313996-78-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products and advanced materials. It is primarily required by analytical laboratories, quality control departments, and R&D teams in the pharmaceutical, agrochemical, and fine chemical industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used for the identification, quantification, and control of process-related impurities in Active Pharmaceutical Ingredients (APIs) and drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, GC, and LC-MS methods for quality control.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA, ICH) by providing definitive impurity characterization data.
• Research & Development: Used in synthetic chemistry and metabolic studies to understand degradation pathways and stability profiles of isoquinoline-based compounds.
• Quality Control & Batch Release Testing: Employed as a system suitability standard and for routine batch analysis to ensure product purity meets stringent specifications.
• Calibration of Analytical Equipment: Acts as a certified reference material for calibrating spectroscopic and chromatographic instruments.

Basic Information

Product Name	Isoquinoline Impurity 19
CAS No.	313996-78-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Isoquinoline Related Compound 19; Isoquinoline Impurity Standard 19; 313996-78-0; Isoquinoline Derivative Impurity; Pharmaceutical Impurity 19 (Isoquinoline); Isoquinoline Process Impurity; Reference Standard for Isoquinoline; Analytical Reference Standard 313996-78-0
EINECS	Contact for details

Quality Control

Every batch of Isoquinoline Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure they meet the exacting standards required for reference materials. A comprehensive Certificate of Analysis (COA), detailing all test results and methodologies, is provided with each shipment to support your quality and regulatory 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 light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and away from direct light exposure to maintain stability and purity.

Specification

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

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