Description

Bromhexine Ep Impurity E is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Bromhexine Hydrochloride. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on method development, validation, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Bromhexine Hydrochloride API and its formulations.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and other chromatographic methods to separate and quantify impurities.
• Stability Studies & Forced Degradation: Used to identify and track impurity profiles in drug substances and products under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections) by providing data to meet EP, USP, and ICH Q3A/B guidelines on impurities.
• Pharmaceutical Research (R&D): Employed in synthetic route optimization and process chemistry to understand and control impurity formation.
• Quality Assurance/Control (QA/QC) Laboratories: Serves as a system suitability and identification standard in routine batch release testing.

Basic Information

Product Name	Bromhexine Ep Impurity E
CAS No.	1660957-93-6
Molecular Formula	C14H20Br2N2
Molecular Weight	376.13 g/mol
Synonyms	Bromhexine Impurity E; Bromhexine Related Compound E; 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine Impurity E; 3,5-Dibromo-2-[(cyclohexylmethyl)amino]methyl]aniline; Bromhexine EP Impurity E; Bromhexine Hydrochloride Impurity E; Bromhexine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Bromhexine Ep Impurity E is manufactured and analyzed under strict quality management systems. The material is characterized and qualified using advanced analytical techniques including HPLC, GC-MS, NMR, and IR spectroscopy to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality protocols are designed to support compliance with relevant pharmacopeial and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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