Description

Dimethindene Impurity H is a specified impurity of the antihistamine drug substance Dimethindene. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is essential for ensuring the purity, safety, and regulatory compliance of the active pharmaceutical ingredient (API). This product is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance.

Application

• Pharmaceutical Reference Standard for Dimethindene API quality control.
• Analytical method development and validation (HPLC, GC, LC-MS).
• Identification and quantification of impurities in drug substance batches.
• Stability studies and forced degradation studies of Dimethindene.
• Calibration of analytical instruments for impurity profiling.
• Research and development of generic pharmaceutical formulations.
• Regulatory filing and submission support (e.g., for ICH guidelines).
• Training and educational purposes in analytical chemistry.

Basic Information

Product Name	Dimethindene Impurity H
CAS No.	1346746-53-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dimethindene Related Compound H; Dimethindene EP Impurity H; Dimethindene USP Impurity H; Dimethindene Process Impurity; 1-[(4-Chlorophenyl)(2-pyridyl)methyl]piperidine Impurity H; Fenistil Impurity H; Forhistal Impurity H
EINECS	Contact for details

Quality Control

Our Dimethindene Impurity H is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, related substances, and identification. We support compliance with major pharmacopoeial standards (USP, EP, JP) and ICH guidelines.

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 conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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