Description

Atropine Impurity 5 CAS NO 88607-15-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of atropine-based pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in drug development and quality control.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Atropine Sulfate API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to meet ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Stability Studies: Used to track the formation of degradation products in atropine formulations under various stress conditions.
• Research & Development: Supports academic and industrial R&D focused on the metabolism, synthesis, and degradation pathways of tropane alkaloids.

Basic Information

Product Name	Atropine Impurity 5
CAS No.	88607-15-2
Molecular Formula	C17H21NO3
Molecular Weight	287.36 g/mol
Synonyms	Atropine Related Compound; Atropine Sulfate Impurity 5; 3α-Hydroxytropane-6β-carboxylic acid, α-phenyl-, methyl ester; Tropine α-phenylacetate; α-Phenyltropine; Methyl α-phenyltropate; Atropine EP Impurity B; Atropine USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Atropine Impurity 5 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity, spectroscopic identification, and quantitative assay. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming compliance with in-house specifications and relevant pharmacopeial guidelines (USP/EP).

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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