Description

Bromhexine Hydrochloride Impurity Tb is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Bromhexine Hydrochloride through precise identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and quality control testing. The reliable supply of this well-characterized impurity is fundamental to maintaining compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Quality Control (QC): Primary use as a certified reference standard for the identification and quantification of Bromhexine Hydrochloride impurities in drug substances and finished products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Stability Studies: Used to monitor the formation and levels of this specific degradation product in Bromhexine Hydrochloride formulations under various storage conditions.
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development (R&D): Employed in synthetic chemistry research to study the degradation pathways and metabolism of Bromhexine Hydrochloride.
• Pharmacopeial Testing: Used as a reference standard to comply with testing requirements outlined in pharmacopeias such as USP, EP, or BP for Bromhexine Hydrochloride.

Basic Information

Product Name	Bromhexine Hydrochloride Impurity Tb
CAS No.	1660957-96-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bromhexine Related Compound Tb; Bromhexine HCl Impurity Tb; Bromhexine Hydrochloride Related Substance Tb; 2-Amino-3,5-dibromobenzylamine Impurity; N-Cyclohexyl-N-methyl-2-amino-3,5-dibromobenzylamine Impurity; Bromhexine Degradation Product Tb; Bromhexine Process Impurity Tb
EINECS	Contact for details

Quality Control

Every batch of Bromhexine Hydrochloride Impurity Tb is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity, purity, and strength. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment ensures the material is suitable for its intended use in pharmaceutical analysis and meets the high standards expected for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Heavy Metals	< 20 ppm

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