Description

Moxonidine Impurity B is a specified impurity and a key reference standard used in the quality control of the active pharmaceutical ingredient (API) Moxonidine. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality assurance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Moxonidine Impurity B in Moxonidine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure API batches comply with strict pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity profiles.
• Stability Studies: Acts as a marker to track impurity formation and degradation pathways of Moxonidine under various stress conditions.
• Research & Development: Utilized in synthetic chemistry R&D to understand and control the formation of this impurity during the API manufacturing process.

Basic Information

Product Name	Moxonidine Impurity B
CAS No.	75439-01-9
Molecular Formula	C9H12ClN5O
Molecular Weight	241.68 g/mol
Synonyms	4-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-6-methoxy-2-methyl-5-pyrimidinamine; 4-Chloro-6-methoxy-2-methyl-5-[(4,5-dihydro-1H-imidazol-2-yl)amino]pyrimidine; Moxonidine Related Compound B; Moxonidine Impurity 2; UNII-9J8F1106VU; 5-[(4,5-Dihydro-1H-imidazol-2-yl)amino]-4-chloro-6-methoxy-2-methylpyrimidine
EINECS	Contact for details

Quality Control

Our Moxonidine Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, USP, and EP standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

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

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