Description

Ipratropium Bromide Impurity 19 (CAS NO 98516-82-6) is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound serves as a specified impurity for the active pharmaceutical ingredient Ipratropium Bromide, enabling precise monitoring and control to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and contract research organization (CRO) sectors, supporting compliance with stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ipratropium Bromide Impurity 19 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to establish impurity limits, perform system suitability tests, and ensure batch-to-batch consistency of Ipratropium Bromide API.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate thorough impurity control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to identify and track the formation of this impurity during API synthesis.

Basic Information

Product Name	Ipratropium Bromide Impurity 19
CAS No.	98516-82-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ipratropium Bromide Related Compound 19; Ipratropium Impurity 19; 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-8-methyl-8-azoniabicyclo[3.2.1]octane bromide 2-phenylpropionate; Atrovent Impurity 19; Ipratropium Bromide EP Impurity G (Check with supplier for equivalence)
EINECS	Contact for details

Quality Control

Our Ipratropium Bromide Impurity 19 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (e.g., by NMR, MS) to ensure identity, strength, quality, and purity. Certificates of Analysis (COA) containing detailed test results against comprehensive specifications are provided and support compliance with relevant pharmacopeial standards. Stability data is available to support recommended storage conditions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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