Description

Bromhexine Related Compound 2 Hcl is a high-purity chemical reference standard and intermediate of significant importance in pharmaceutical development and quality control. This compound is critical for ensuring the accuracy and reliability of analytical methods used to assess the purity and stability of the active pharmaceutical ingredient, Bromhexine Hydrochloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, regulatory compliance testing, and impurity profiling. The availability of a well-characterized related compound is essential for maintaining stringent quality standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Bromhexine Hydrochloride drug substances and finished products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of pharmaceutical ingredients, complying with ICH guidelines.
• Pharmacopeial Testing: Applied in testing to meet the specifications outlined in various pharmacopeias such as USP, EP, or BP for Bromhexine Hydrochloride.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Bromhexine Hydrochloride.
• Research & Development: Acts as a key intermediate or impurity standard in synthetic chemistry research and the development of new analytical methodologies.

Basic Information

Product Name	Bromhexine Related Compound 2 Hcl
CAS No.	32193-43-4
Molecular Formula	C14H21Br2N2 • HCl
Molecular Weight	414.60 g/mol
Synonyms	Bromhexine Impurity 2 Hydrochloride; Bromhexine Related Substance 2 HCl; 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine Hydrochloride; 3,5-Dibromo-2-[(cyclohexylmethyl)amino]methyl]aniline Hydrochloride; Bromhexine EP Impurity B HCl; Bromhexine Hydrochloride Impurity 2; Bromhexine HCl Impurity 2; N-Cyclohexyl-N-methyl-2-amino-3,5-dibromobenzylamine Hydrochloride
EINECS	Contact for details

Quality Control

Our Bromhexine Related Compound 2 Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure it meets the high-purity standards required for use as a reference material. Specifications are aligned with the requirements of major pharmacopeias. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile by validated methods (e.g., HPLC, NMR) is provided with every shipment to guarantee traceability and compliance for your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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 standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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