Description

Atropine Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of atropine-based pharmaceutical products, ensuring their safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Atropine Sulfate API and finished drug products.
• Analytical Method Development: Used as a standard to develop and validate sensitive HPLC, UPLC, or GC methods for impurity detection.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and batch release to ensure drug substance and product purity meets pharmacopeial standards (USP, EP, BP).
• Stability Studies: Employed to monitor the formation of degradation products in atropine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Academic and Clinical Research: Supports studies investigating the metabolism, pharmacokinetics, and toxicology of atropine and related tropane alkaloids.

Basic Information

Product Name	Atropine Impurity 4
CAS No.	3423-23-2
Molecular Formula	C17H21NO3
Molecular Weight	287.35 g/mol
Synonyms	Noratropine; 3-Tropanyl 2-hydroxy-2-phenylacetate; 8-Azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2-phenylacetate; Tropan-3α-yl α-hydroxybenzeneacetate; Atropine Related Compound; Atropine EP Impurity D; Atropine USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Atropine Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with relevant pharmacopeial guidelines and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere when appropriate to ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white solid
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 ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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