Description

Pinaverium Bromide Impurity 6 is a specified impurity of the antispasmodic pharmaceutical agent Pinaverium Bromide. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories for research and regulatory compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity 6 in Pinaverium Bromide drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (e.g., HPLC, UPLC) to monitor and control this specific impurity.
• Stability Studies: Employed in forced degradation and long-term stability testing to understand the degradation pathways of Pinaverium Bromide.
• Quality Control & Assurance: Serves as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity profiles and specifications.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the manufacturing process.

Basic Information

Product Name	Pinaverium Bromide Impurity 6
CAS No.	53330-19-1
Molecular Formula	C26H41BrN2O4
Molecular Weight	525.52 g/mol
Synonyms	4-[(2-Bromo-4,5-dimethoxyphenyl)methyl]-4-[2-[2-(6,6-dimethylbicyclo[3.1.1]hept-2-yl)ethoxy]ethyl]morpholin-4-ium Bromide; Pinaverium Bromide Related Compound B; Pinaverium Bromide EP Impurity B; Pinaverium Bromide USP Impurity; 1-(3,4-Dimethoxybenzyl)-1-[2-(6,6-dimethyl-2-norpinanyl)ethoxy]ethyl]piperidinium Bromide Impurity; Pinaverium Impurity F (Check Source); Pinaverium Bromide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Pinaverium Bromide Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w
Assay (on dried basis)	95.0% - 105.0%

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