Description

Diphenidol Impurity 4 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiemetic drug Diphenidol through rigorous impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments engaged in drug development and compliance. The precise characterization of this impurity is fundamental for meeting stringent pharmacopeial standards and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Diphenidol Impurity 4 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating stability-indicating HPLC, UPLC, or GC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels and ensure drug substance and product specifications are met for every production batch.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation pathways and establish shelf-life.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA, PMDA) by providing characterized impurity data.
• Pharmacopeial Testing: Serves as a standard for testing against monographs in pharmacopeias such as USP, EP, or JP where specified.
• Research on Degradation Pathways: Used in academic and industrial research to study the chemical stability and degradation mechanisms of Diphenidol.

Basic Information

Product Name	Diphenidol Impurity 4 Hcl
CAS No.	94908-95-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,1-Diphenyl-4-piperidinol hydrochloride; α,α-Diphenyl-1-piperidinebutanol hydrochloride; Diphenidol Related Compound; Diphenidol Impurity D HCl; Diphenidol EP Impurity D HCl; Diphenidol Hydrochloride Impurity 4; 4-Piperidinol, 1,1-diphenyl-, hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Diphenidol Impurity 4 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines (USP, EP) for pharmaceutical impurities.

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 light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and handled under conditions that minimize exposure to light and atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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)	≤ 5.0%

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