Description

Dicycloverine Impurity CAS NO 91975-81-4 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Dicycloverine Hydrochloride. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and regulatory compliance testing. The availability of this well-characterized impurity supports robust quality control processes in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dicycloverine Hydrochloride API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, GC, or other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA/ANDA) to regulatory bodies like the FDA and EMA.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of drug products.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, synthesis by-products, and metabolism of Dicycloverine.

Basic Information

Product Name	Dicycloverine Impurity
CAS No.	91975-81-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dicycloverine Related Compound; Dicycloverine Process Impurity; Dicyclomine Impurity; 2-(Diethylamino)ethyl 1-cyclohexylcyclohexanecarboxylate impurity; 1-Cyclohexylcyclohexanecarboxylic acid 2-(diethylamino)ethyl ester impurity; Bentyl Impurity; Dicycloverine Hydrochloride Impurity A (Potential); Dicyclomine Hydrochloride Impurity
EINECS	Contact for details

Quality Control

Every batch of Dicycloverine Impurity (CAS 91975-81-4) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.