Description

Minoxidil Ep Impurity C is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound serves as a specified impurity for the active pharmaceutical ingredient Minoxidil, enabling precise quantification and monitoring to ensure drug safety and efficacy. It is an essential material for pharmaceutical R&D laboratories, quality assurance units, and regulatory compliance teams working on generic or innovator drug formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Minoxidil-related impurities in drug substances and products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity profiles and ensure batch-to-batch consistency.
• Regulatory Submissions: Supports the filing of drug master files (DMFs), ANDAs, and INDs by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Pharmacopoeial Testing: Used to verify compliance with pharmacopoeial monographs such as USP, EP, or BP for Minoxidil.
• Research & Development: Aids in synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Minoxidil Ep Impurity C
CAS No.	1798387-81-1
Molecular Formula	C9H15N5O
Molecular Weight	209.25 g/mol
Synonyms	Minoxidil Impurity C; Minoxidil Related Compound C; 2,4-Diamino-6-piperidinopyrimidine 3-oxide; 6-(1-Piperidinyl)-2,4-pyrimidinediamine 3-oxide; Minoxidil EP Impurity C; Minoxidil USP Impurity C; Minoxidil Process Impurity; MIN-C
EINECS	Contact for details

Quality Control

Our Minoxidil Ep Impurity C is manufactured under strict quality management systems. Each batch is characterized and tested using validated analytical methods, including HPLC for purity and related substances, and spectroscopic techniques (NMR, MS) for structural confirmation. We provide comprehensive Certificates of Analysis (COA) detailing batch-specific results, ensuring traceability and compliance with current pharmacopoeial standards (EP, USP) and ICH guidelines. Our quality commitment ensures material suitability for its intended use in regulatory and analytical applications.

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 should be kept in a desiccated environment. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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