Description

Ipratropium Bromide Impurity E is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Ipratropium Bromide. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing of respiratory medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ipratropium Bromide Impurity E in API batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Ipratropium Bromide under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity characterization, synthesis pathway research, and process chemistry optimization.

Basic Information

Product Name	Ipratropium Bromide Impurity E
CAS No.	183626-76-8
Molecular Formula	C20H30BrNO3
Molecular Weight	412.37 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 E; Ipratropium Impurity E; Ipratropium Bromide EP Impurity E; Ipratropium Bromide USP Impurity E
EINECS	Contact for details

Quality Control

Our Ipratropium Bromide Impurity E is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including purity by HPLC, is provided with every shipment to support your regulatory and quality needs.

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. Handle the material under appropriate laboratory conditions to prevent contamination.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.