Description

Diphenidol Impurity 8 Dihcl CAS NO 88826-31-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiemetic pharmaceutical, Diphenidol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Diphenidol hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemical behavior of Diphenidol, aiding in formulation optimization.

Basic Information

Item	Detail
Product Name	Diphenidol Impurity 8 Dihcl
CAS No.	88826-31-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Diphenidol Related Compound 8; Diphenidol Hydrochloride Impurity 8; 1,1-Diphenyl-4-piperidinol Impurity; α,α-Diphenyl-1-piperidinebutanol Impurity; 4-(Diphenylhydroxymethyl)-1-methylpiperidine Impurity; Vontrol Impurity; Cephalol Impurity
EINECS	Contact for details

Quality Control

Every batch of Diphenidol Impurity 8 Dihcl is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and traceability 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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