Description

Atropine Ep Impurity E CAS NO 949092-65-3 is a high-purity chemical reference standard specifically identified as a process-related impurity of Atropine. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily required by analytical laboratories, quality control departments, and regulatory affairs teams within the pharmaceutical and biotechnology industries for method validation and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) for the identification and quantification of Atropine Ep Impurity E in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) and Q3A(R2) guidelines.
• Quality Control and Batch Release Testing: Essential for routine QC testing of Atropine sulfate or related drug substances to monitor and control impurity levels against specified limits.
• Regulatory Submission and Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity data required for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Pharmacopoeial Testing: Used as a reference standard for testing against monographs in the USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other international pharmacopoeias.

Basic Information

Product Name	Atropine Ep Impurity E
CAS No.	949092-65-3
Molecular Formula	C17H23NO3
Molecular Weight	289.37 g/mol
Synonyms	(1R,3r,5S)-8-Methyl-8-azabicyclo[3.2.1]octan-3-yl (2S)-3-hydroxy-2-phenylpropanoate; Tropine (S)-Tropate Impurity E; Atropine Related Compound E; Atropine Sulfate Impurity E; Atropine EP Impurity E; Atropine Impurity E (EP); 949092-65-3
EINECS	Contact for details

Quality Control

Every batch of Atropine Ep Impurity E (CAS 949092-65-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and relevant pharmacopoeial guidelines (e.g., EP, USP). Comprehensive Certificates of Analysis (COA) are provided, detailing purity, identity, and impurity profiles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to preserve 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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