Description

Noscapine Impurity 8 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing noscapine. It is primarily required by pharmaceutical manufacturers and contract research organizations (CROs) for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in noscapine active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels remain within specified safety thresholds.
• Regulatory Submissions: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products in noscapine formulations under various stress conditions.
• Research & Development: Supports chemical and pharmacological research into the metabolism, degradation pathways, and synthesis of noscapine and related compounds.

Basic Information

Product Name	Noscapine Impurity 8
CAS No.	64179-42-6
Molecular Formula	C22H23NO7
Molecular Weight	413.42 g/mol
Synonyms	1,2,3,4-Tetrahydro-8-methoxy-2-methyl-5-[(7,8-dimethoxy-4-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)methyl]-6H-[1,3]dioxolo[4,5-g]isoquinolin-6-one; Narcotine Impurity 8; Noscapine Related Compound 8; Opianic Acid Derivative; 5,6,7,8-Tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl-methyl-6,7-dimethoxy-3-methyl-1,3-dihydroisobenzofuran-1-one
EINECS	Contact for details

Quality Control

Every batch of Noscapine Impurity 8 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with ICH Q3A/B guidelines and to meet the exacting standards for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

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

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