Description

Ipratropium Bromide Ep Impurity F Bromide is a high-purity reference standard and a key process-related impurity used in the pharmaceutical manufacturing of Ipratropium Bromide. This compound is critical for ensuring the quality, safety, and efficacy of the final active pharmaceutical ingredient (API) by enabling accurate identification and quantification of impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality control, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Primary use as a reference standard for the identification and quantification of Ipratropium Bromide Ep Impurity F in API batches.
• Essential component in analytical method development and validation for Ipratropium Bromide according to EP, USP, and ICH guidelines.
• Critical for pharmaceutical quality control (QC) and stability studies to monitor impurity profiles.
• Used in regulatory submissions and dossier preparation to demonstrate control of the manufacturing process.
• Valuable material for research and development focused on impurity synthesis, characterization, and degradation pathways.
• Supports GMP-compliant manufacturing by providing a traceable benchmark for impurity control strategies.

Basic Information

Product Name	Ipratropium Bromide Ep Impurity F Bromide
CAS No.	60018-35-1
Molecular Formula	C20H30BrNO3
Molecular Weight	412.36 g/mol
Synonyms	8-Azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, (1R,3r,5S)-; Ipratropium Bromide Impurity F; Ipratropium Related Compound F; (1R,3r,5S)-3-((RS)-3-Hydroxy-2-phenylpropanoyloxy)-8-isopropyl-8-methyl-8-azoniabicyclo[3.2.1]octane Bromide; Tropanol, 3-hydroxy-8-isopropyl-8-methyl-, ester with hydrotropic acid, bromide; Atrovent Impurity F
EINECS	Contact for details

Quality Control

Every batch of Ipratropium Bromide Ep Impurity F Bromide is manufactured and tested under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs. Comprehensive analytical characterization is performed using advanced techniques like HPLC, NMR, and MS. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.