Description

Enpiroline Impurity 1 CAS NO 52300-94-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products by serving as a key impurity marker. It is primarily needed by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in method development and validation.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of impurities in Enpiroline or related drug substances and products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical manufacturing to ensure products meet stringent pharmacopeial (e.g., USP, EP, ICH) specifications for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Academic & Industrial Research: Supports metabolic studies, pharmacokinetic research, and synthetic chemistry investigations related to the Enpiroline structural class.

Basic Information

Product Name	Enpiroline Impurity 1
CAS No.	52300-94-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Enpiroline Related Compound A; Enpiroline EP Impurity A; Enpiroline USP Impurity; Enpiroline Process Impurity; 1H-Pyrrolo[3,2-c]pyridine-2-carboxylic acid, 4,5,6,7-tetrahydro-7-oxo-, ethyl ester (possible IUPAC based on CAS); Enpiroline Degradant; Enpiroline Specified Impurity.
EINECS	Contact for details

Quality Control

Every batch of Enpiroline Impurity 1 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing results for assay, related substances, residual solvents, and other critical parameters, is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere if the compound is easily oxidized.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 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.