Description

Noscapine Impurity 7 Sodium Salt (Noscapinic Acid Sodium Salt) is a high-purity reference standard and impurity used in pharmaceutical research and development. This compound is critical for the quality control and analytical characterization of the antitussive drug Noscapine, ensuring product safety and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Noscapine and its related substances.
• Impurity Profiling: Essential for identifying, monitoring, and controlling Noscapine Impurity 7 during drug substance and drug product manufacturing to meet ICH guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for purity and assay testing.
• Stability Studies: Employed to track the formation of degradation products in Noscapine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and specifications.
• Pharmacological Research: Used in studies investigating the metabolism and pharmacokinetics of Noscapine and its derivatives.

Basic Information

Product Name	Noscapine Impurity 7 Sodium Salt (Noscapinic Acid Sodium Salt)
CAS No.	143976-78-7
Molecular Formula	C22H22NO7•Na
Molecular Weight	435.41 g/mol
Synonyms	Noscapinic Acid Sodium Salt; 6,7-Dimethoxy-3-((R)-5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)isobenzofuran-1(3H)-one Sodium Salt; Noscapine Related Compound; Noscapine Acid Sodium Salt; Noscapine Impurity 7 (Sodium Salt); 1(3H)-Isobenzofuranone, 6,7-dimethoxy-3-[(5R)-5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl]-, sodium salt (1:1); Opianic Acid Sodium Salt Derivative
EINECS	Contact for details

Quality Control

Our Noscapine Impurity 7 Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS) to ensure it meets the stringent requirements for pharmaceutical impurity standards. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified criteria.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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