Description

Ipratropium Bromide Impurity 12 is a designated impurity of the active pharmaceutical ingredient (API) Ipratropium Bromide, a key anticholinergic bronchodilator. This compound is critical for pharmaceutical development and quality control, serving as a reference standard to ensure the purity, safety, and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ipratropium Bromide Impurity 12 in API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurity profiles during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Indicating Studies: Helps assess the degradation pathways and shelf-life of Ipratropium Bromide formulations under various stress conditions.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development (R&D): Utilized in synthetic chemistry research to study the formation and fate of this specific impurity during the API synthesis process.

Basic Information

Product Name	Ipratropium Bromide Impurity 12
CAS No.	60233-19-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ipratropium Related Compound; Ipratropium Bromide EP Impurity; Ipratropium Bromide USP Impurity; 8-Azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, (1R,3r,5S)-; Atrovent Impurity; (1R,3r,5S)-3-((RS)-3-Hydroxy-2-phenylpropanoyloxy)-8-isopropyl-8-methyl-8-azoniabicyclo[3.2.1]octane bromide
EINECS	Contact for details

Quality Control

Our Ipratropium Bromide Impurity 12 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.