Description

Otilonium Bromide Impurity 11 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Otilonium Bromide during its development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) focused on method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Otilonium Bromide API.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical manufacturing to meet ICH guidelines.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization.
• Stability Studies: Employed as a marker to monitor the formation of degradation products under various stress conditions.
• Research & Development: Used in synthetic chemistry research to understand and control impurity formation pathways during API synthesis.

Basic Information

Product Name	Otilonium Bromide Impurity 11
CAS No.	1007652-84-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Otilonium Bromide Related Compound 11; Otilonium Impurity 11; 4-[(2-Butoxyethoxy)methyl]-N,N-diethyl-N-methylbenzenaminium Bromide Impurity; Spasmomen Impurity 11; UNII-Contact for details; Benzenaminium, 4-[(2-butoxyethoxy)methyl]-N,N-diethyl-N-methyl-, bromide (1:1); Otilonium Bromide EP Impurity B (Potential Synonym)
EINECS	Contact for details

Quality Control

Every batch of Otilonium Bromide Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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) and must be kept under inert conditions or in a desiccator to prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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