Description

Aminocaproic Acid Impurity 1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety profile of the active pharmaceutical ingredient, Aminocaproic Acid, a hemostatic agent. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers engaged in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Aminocaproic Acid API and finished drug products.
• Analytical Method Development: A critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of the drug substance, supporting compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and metabolic pathway studies related to antifibrinolytic agents.

Basic Information

Product Name	Aminocaproic Acid Impurity 1
CAS No.	22993-71-1
Molecular Formula	C7H15NO2
Molecular Weight	145.20 g/mol
Synonyms	6-Aminohexanoic Acid Impurity 1; EACA Impurity 1; (6-Aminohexanoic acid) Impurity A; Hexanoic acid, 6-amino-, impurity; 6-Aminocaproic Acid Related Compound 1; Amino Caproic Acid Impurity 1; 22993-71-1; Amicar Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Aminocaproic Acid Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches 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
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.