Description

Minoxidil Impurity D is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Minoxidil-based pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in the development and production of cardiovascular and hair growth treatments.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Minoxidil Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Minoxidil formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Facilitates chemical and metabolic studies related to Minoxidil, aiding in the understanding of its degradation pathways and behavior.

Basic Information

Product Name	Minoxidil Impurity D
CAS No.	75105-16-7
Molecular Formula	C9H15N5O
Molecular Weight	209.25 g/mol
Synonyms	2,4-Diamino-6-piperidinopyrimidine 3-oxide; 6-(1-Piperidinyl)-2,4-pyrimidinediamine 3-oxide; Minoxidil Related Compound D; Minoxidil EP Impurity D; Minoxidil USP Impurity D; 6-Piperidin-1-yl-1H-pyrimidine-2,4-diamine 3-oxide
EINECS	Contact for details

Quality Control

Our Minoxidil Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data. We support compliance with USP, EP, and ICH guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

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

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