Description

Diphenidol Impurity 6 Dihcl is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker for the antiemetic drug Diphenidol, enabling precise analytical method development and validation. It is essential for quality control laboratories, regulatory compliance, and process chemistry teams working on active pharmaceutical ingredient (API) manufacturing. Ensuring the integrity and traceability of this impurity is fundamental for maintaining drug safety and efficacy standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Diphenidol-related impurities in API and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles during drug synthesis and stability studies.
• Quality Control & Assurance: Employed in routine QC testing to ensure Diphenidol API and drug products meet stringent pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and CMC sections.
• Process Chemistry & Optimization: Used to track and control the formation of this specific impurity during the synthesis, purification, and scale-up of Diphenidol.
• Stability Studies: Acts as a benchmark to assess degradation pathways and establish shelf-life specifications for Diphenidol-containing medications.

Basic Information

Product Name	Diphenidol Impurity 6 Dihcl
CAS No.	63114-16-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diphenidol Related Compound 6; Diphenidol Dihydrochloride Impurity 6; 1,1-Diphenyl-4-piperidinobutanol Impurity; α,α-Diphenyl-1-piperidinebutanol Impurity 6; Vontrol Impurity 6; Diphenidol HCl Impurity 6; Diphenidol EP Impurity 6; Diphenidol USP Impurity 6
EINECS	Contact for details

Quality Control

Our Diphenidol Impurity 6 Dihcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
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 guidelines
Water Content (KF)	≤ 5.0% w/w

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