Description

Rilmenidine Impurity A CAS NO 54187-44-9 is a designated impurity standard used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient (API) Rilmenidine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Rilmenidine Impurity A in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity profile data required by agencies like the FDA, EMA, and PMDA.
• Pharmaceutical Research: Utilized in research settings to study the metabolic pathways and degradation behavior of Rilmenidine.
• Quality Control Testing: Serves as a system suitability standard and for routine batch analysis to ensure impurity levels are within specified limits.

Basic Information

Product Name	Rilmenidine Impurity A
CAS No.	54187-44-9
Molecular Formula	C10H17N3O2
Molecular Weight	211.26 g/mol
Synonyms	N-(Dicyclopropylmethyl)-2-oxo-1-imidazolidineacetamide; (RS)-N-(Dicyclopropylmethyl)-2-oxoimidazolidine-1-acetamide; 1-[(Dicyclopropylmethyl)carbamoyl]methyl]imidazolidin-2-one; Rilmenidine Related Compound A; Rilmenidine EP Impurity A; Rilmenidine USP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Rilmenidine Impurity A is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing to ensure identity, purity, and consistency, aligning with pharmacopeial standards (e.g., USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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