Description

Diphenidol Impurity 2 is a designated reference standard used for the analytical profiling and quality control of the antiemetic pharmaceutical agent, Diphenidol. This high-purity chemical is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Identification and Profiling: Used in HPLC, GC, and LC-MS analyses to identify, characterize, and quantify Diphenidol-related impurities during drug development and manufacturing.
• Method Development and Validation: A critical component in establishing and validating stability-indicating assay methods as per ICH guidelines.
• Quality Control and Batch Release: Employed in routine QC testing of active pharmaceutical ingredients (APIs) and finished drug products to ensure they meet specified impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Used to monitor the formation of degradation products in Diphenidol formulations under various stress conditions.

Basic Information

Item	Detail
Product Name	Diphenidol Impurity 2
CAS No.	63645-18-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1-Diphenyl-4-piperidinobutanol Impurity; Diphenidol Related Compound; α,α-Diphenyl-1-piperidinebutanol Impurity; Diphenidol EP Impurity; Diphenidol USP Impurity; Vontrol Impurity
EINECS	Contact for details

Quality Control

Every batch of Diphenidol Impurity 2 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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