Description

Bromhexine Impurity E Iodide is a high-purity reference standard specifically used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Bromhexine Hydrochloride. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and production. The precise identification and quantification of this impurity are vital for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Bromhexine Impurity E in drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: Serves as a system suitability standard and for preparing calibration curves in routine QC testing of Bromhexine Hydrochloride API.
• Stability Studies: Employed to monitor the formation of degradation impurities in Bromhexine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate control over the impurity profile.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Bromhexine.

Basic Information

Product Name	Bromhexine Impurity E Iodide
CAS No.	1661064-00-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bromhexine Related Compound E; Bromhexine Impurity E; Bromhexine EP Impurity E; Bromhexine USP Impurity E; N-Cyclohexyl-N-methyl-2-amino-3,5-dibromobenzylamine Hydroiodide; 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzenemethanamine Hydroiodide
EINECS	Contact for details

Quality Control

Our Bromhexine Impurity E Iodide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with the requirements of major pharmacopeias, including USP and EP.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle with appropriate precautions in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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