Description

Moxonidine Impurity A is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Moxonidine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• As a certified reference standard for the identification and quantification of Moxonidine Impurity A in Moxonidine API and finished dosage forms.
• For analytical method development and validation (HPLC, UPLC, GC) in pharmaceutical quality control laboratories.
• In stability studies to monitor the formation of degradation products under various stress conditions.
• For regulatory compliance and submission, providing essential data for drug master files (DMFs) and regulatory filings (e.g., FDA, EMA).
• As a critical component in pharmaceutical research and development for impurity profiling and characterization.
• Used by contract research organizations (CROs) and testing laboratories offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Moxonidine Impurity A
CAS No.	352457-35-3
Molecular Formula	C9H12ClN5O
Molecular Weight	241.68 g/mol
Synonyms	4-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-6-methoxy-2-methylpyrimidin-5-amine; 5-Amino-4-chloro-6-methoxy-2-methylpyrimidine; Moxonidine Related Compound A; Moxonidine EP Impurity A; Moxonidine USP Impurity A; Moxonidine Degradation Product; Moxonidine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Moxonidine Impurity A is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
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.