Description

Ipratropium Bromide Impurity F (Mixture Of Diastereomers) is a defined chemical reference standard used in the pharmaceutical development and quality control of Ipratropium Bromide, a widely prescribed bronchodilator. This impurity standard is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on respiratory medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ipratropium Bromide Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring every batch meets stringent purity specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities, a key requirement for drug approval.
• Research & Process Chemistry: Aids in understanding the synthesis pathway of Ipratropium Bromide and helps chemists optimize processes to minimize the formation of this impurity.

Basic Information

Product Name	Ipratropium Bromide Impurity F (Mixture Of Diastereomers)
CAS No.	17812-46-3
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,8r)-Isomer; Ipratropium Related Compound F; (1R,3r,5S,8r)-3-((RS)-3-Hydroxy-2-phenylpropionyloxy)-8-isopropyl-8-methyl-8-azoniabicyclo[3.2.1]octane Bromide; Ipratropium Bromide EP Impurity F; Ipratropium Bromide Diastereomeric Impurity; Tropanol, 8-isopropyl-8-methyl-3-(3-hydroxy-2-phenylpropionyloxy)-, bromide, diastereomer
EINECS	Contact for details

Quality Control

Every batch of Ipratropium Bromide Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0% (sum of diastereomers)
Individual Diastereomer Ratio	Specified on COA
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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