Description

Amiloride Ep Impurity C is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Amiloride by accurately identifying and quantifying related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions engaged in method development and validation. The product is supplied with comprehensive analytical data to support regulatory compliance and robust quality systems.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Amiloride Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Amiloride batches meet the stringent impurity limits specified in pharmacopoeial monographs (e.g., USP, EP, BP).
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Amiloride under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides critical data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research & Development: Supports synthetic route optimization and process chemistry studies by helping to identify and track process-related impurities.

Basic Information

Item	Details
Product Name	Amiloride Ep Impurity C
CAS No.	76599-74-1
Molecular Formula	C6H8ClN7O
Molecular Weight	229.63 g/mol
Synonyms	3,5-Diamino-6-chloro-N-(diaminomethylene)pyrazine-2-carboxamide; Amiloride Impurity C; Amiloride Related Compound C; 6-Chloro-3,5-diamino-N-(aminoiminomethyl)pyrazine-2-carboxamide; 2-Pyrazinecarboxamide, 6-chloro-3,5-diamino-N-(aminoiminomethyl)-; Amiloride Impurity 3; Amiloride EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Amiloride Ep Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopoeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, MS, NMR, and IR spectroscopy. Our commitment to traceability and data integrity supports your regulatory and quality assurance requirements.

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 must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere conditions.

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 impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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