Description

Ipratropium Bromide Impurity 14 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in Ipratropium Bromide, a widely used bronchodilator. It serves as a vital tool for analytical chemists and quality assurance professionals in the pharmaceutical industry, ensuring drug safety, efficacy, and regulatory compliance. The availability of a well-characterized impurity standard is fundamental for method validation and maintaining stringent quality control throughout the manufacturing lifecycle.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation in QC laboratories.
• Impurity Profiling & Identification: Used in HPLC, UPLC, and LC-MS systems to identify and quantify this specific impurity in Ipratropium Bromide Active Pharmaceutical Ingredient (API) and finished drug products.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways in stability testing of Ipratropium Bromide formulations.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this impurity during API manufacturing.
• Pharmacopoeial Testing: Used to ensure batch-to-batch consistency and compliance with pharmacopoeial monographs (e.g., USP, EP, BP) for Ipratropium Bromide.

Basic Information

Product Name	Ipratropium Bromide Impurity 14
CAS No.	183626-75-7
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)-; (3-endo)-3-Hydroxy-8-isopropyl-1-methyl-8-azabicyclo[3.2.1]oct-8-yl α-phenyl-β-hydroxy-β-phenylpropionate bromide; Ipratropium Bromide Related Compound; Ipratropium Bromide EP Impurity D; Ipratropium Bromide USP Impurity; Tropanol, 8-isopropyl-3-α-hydroxy-1-α-H,5-α-H-tropanium bromide phenylacetate; Ipratropium Impurity 14
EINECS	Contact for details

Quality Control

Every batch of Ipratropium Bromide Impurity 14 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization using advanced spectroscopic and chromatographic techniques, including NMR, Mass Spectrometry, and HPLC, to confirm identity and ensure high purity. Our products are tested to meet stringent in-house specifications aligned with ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a desiccated area to prevent degradation from atmospheric moisture.

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%
Assay (by HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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