Description

Atropine Impurity 5 (Mixture Of Isomers) is a defined chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing atropine or its derivatives. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Atropine Impurity 5 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in atropine-based formulations.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification in regulatory filings to agencies like the FDA, EMA, and PMDA.
• Research & Development: Used in academic and industrial R&D to study the metabolism, pharmacokinetics, and toxicological profile of atropine-related compounds.

Basic Information

Product Name	Atropine Impurity 5 (Mixture Of Isomers)
CAS No.	6535-26-8
Molecular Formula	C17H23NO3
Molecular Weight	289.37 g/mol
Synonyms	Atropine Related Compound; Atropine Isomer Impurity; 3α-Hydroxytropane-2β-carboxylic acid, α-phenyl-, methyl ester (isomer mixture); Tropine tropate (isomer mixture); DL-Hyoscyamine; Atropine EP Impurity B; Atropine USP Related Compound; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Our Atropine Impurity 5 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for analytical applications. Each batch is characterized and tested using advanced analytical techniques, including HPLC, GC, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile. Our quality commitment aligns with ISO 9001 standards and supports compliance with ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0% (Area %)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Specific Rotation	Contact for details

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