Description

Bambuterol Hcl Imp.(Ep) CAS NO 1391921-22-4 is a high-purity reference standard and impurity used in the pharmaceutical development and quality control of Bambuterol Hydrochloride. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on respiratory therapeutics and pharmacopoeial (EP) method validation.

Application

• As a certified reference standard for the identification and quantification of impurities in Bambuterol Hydrochloride API.
• For method development and validation in HPLC and LC-MS analysis to meet European Pharmacopoeia (EP) and other international monographs.
• In quality control (QC) laboratories to monitor and control impurity profiles during API manufacturing.
• For stability studies and forced degradation studies to understand the degradation pathways of Bambuterol.
• As a critical material in regulatory submissions (e.g., CMC sections) to support drug approval processes.
• Used in academic and industrial research investigating the metabolism and pharmacokinetics of β-2 agonist drugs.

Basic Information

Product Name	Bambuterol Hcl Imp.(Ep)
CAS No.	1391921-22-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bambuterol Related Compound; Bambuterol Hydrochloride Impurity; Bambuterol EP Impurity; Bambuterol HCl Specified Impurity; Bambuterol Process Related Substance; 1-(3,5-Bis(dimethylcarbamoyloxy)phenyl)-2-(tert-butylamino)ethanol Hydrochloride Impurity; Terbutaline Prodrug Impurity
EINECS	Contact for details

Quality Control

Our Bambuterol Hcl Imp.(Ep) is manufactured under strict quality systems to ensure identity, purity, and consistency. Each batch is characterized and tested against pharmacopoeial standards (e.g., EP) using advanced analytical techniques. Comprehensive Certificates of Analysis (COA) are provided, detailing results for assay, related substances, and identification. We support our clients' regulatory needs with full traceability and documentation.

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 powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Complies with EP limits
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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