Description

Bromhexine Hydrochloride Impurity I is a high-purity 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 rigorous impurity profiling. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The availability of this well-characterized impurity standard is essential for method validation and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Bromhexine Hydrochloride API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products in Bromhexine Hydrochloride formulations under various stress conditions.
• Research & Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and metabolic profiling of Bromhexine and related compounds.

Basic Information

Product Name	Bromhexine Hydrochloride Impurity I
CAS No.	1631131-52-6
Molecular Formula	C14H21Br2N3O2
Molecular Weight	423.15 g/mol
Synonyms	Bromhexine Impurity I; Bromhexine Related Compound I; 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine Impurity I; 2-Amino-3,5-dibromo-N-((cyclohexylamino)methyl)-N-methylaniline; N-Cyclohexyl-N-methyl-2-amino-3,5-dibromobenzylamine; Bromhexine HCl Impurity I; Bromhexine Hydrochloride EP Impurity I; Bromhexine Hydrochloride USP Impurity I
EINECS	Contact for details

Quality Control

Our Bromhexine Hydrochloride Impurity I is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and residual solvent analysis to ensure compliance with pharmacopeial standards (USP/EP/BP). A detailed Certificate of Analysis (COA) is provided with every shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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