Description

Diphenidol Impurity 7 Hcl is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of related substances in the active pharmaceutical ingredient Diphenidol, ensuring drug safety and regulatory compliance. It is primarily required by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries for method development and validation.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Diphenidol API and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of pharmaceutical products.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand drug decomposition pathways.
• Chemical Research: Used in academic and industrial research focused on the synthesis, metabolism, and degradation chemistry of Diphenidol.

Basic Information

Product Name	Diphenidol Impurity 7 Hcl
CAS No.	17874-62-3
Molecular Formula	C21H27NO • HCl
Molecular Weight	345.91 g/mol
Synonyms	1,1-Diphenyl-4-piperidinobutanol Hydrochloride Impurity 7; α,α-Diphenyl-1-piperidinebutanol HCl Related Compound; Diphenidol Related Substance 7; 4-(Diphenylhydroxymethyl)-1-methylpiperidine Hydrochloride Impurity; 1-Methyl-4-(α,α-diphenyl-γ-hydroxybutyl)piperidine HCl Impurity; Vontrol Impurity 7; Cephadol Related Compound 7
EINECS	Contact for details

Quality Control

Every batch of Diphenidol Impurity 7 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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