Description

Aclidinium Bromide Impurity 3 ((S)-Aclidinium Bromide) is a specific stereoisomeric impurity of the active pharmaceutical ingredient Aclidinium Bromide, a long-acting muscarinic antagonist used in respiratory medicine. This high-purity reference standard is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is an essential material for research and development scientists, quality assurance laboratories, and regulatory affairs professionals working on inhalation therapies, ensuring the safety and efficacy of the final drug product by accurately monitoring and controlling impurity profiles.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the (S)-enantiomer impurity in Aclidinium Bromide drug substance and finished products.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for the precise separation and analysis of stereoisomeric impurities.
• Quality Control & Assurance: Employed in routine batch testing to ensure impurity levels remain within International Council for Harmonisation (ICH) and pharmacopeial (USP, EP) specified limits.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Stability Studies: Used as a marker to track potential degradation pathways and isomerization of Aclidinium Bromide under various storage conditions.
• Research on Pharmacological Activity: Facilitates studies to understand the biological activity and safety profile of individual enantiomers.

Basic Information

Item	Details
Product Name	Aclidinium Bromide Impurity 3 ((S)-Aclidinium Bromide)
CAS No.	320346-78-9
Molecular Formula	C26H30BrNO4+
Molecular Weight	500.43 g/mol (for cation)
Synonyms	(3R)-3-{[(2S)-2-Hydroxy-2,2-di(thiophen-2-yl)acetyl]oxy}-1-(3-phenoxypropyl)-1-azoniabicyclo[2.2.2]octane Bromide; (S)-Enantiomer of Aclidinium Bromide; LAS 34273 Impurity; LAS-W 330 Impurity; Aclidinium Bromide Stereoisomer; Aclidinium Related Compound 3
EINECS	Contact for details

Quality Control

Every batch of Aclidinium Bromide Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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