Description

Bromhexine Impurity F CAS NO 14860-48-1 is a specified impurity of the active pharmaceutical ingredient Bromhexine Hydrochloride, used as a critical reference standard in analytical chemistry. This compound is essential for ensuring the quality, safety, and regulatory compliance of Bromhexine-based pharmaceutical products by enabling accurate identification and quantification of impurities. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Bromhexine Impurity F in drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing in QC labs to ensure drug purity meets pharmacopoeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation impurities in Bromhexine formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and in bioanalytical studies.

Basic Information

Product Name	Bromhexine Impurity F
CAS No.	14860-48-1
Molecular Formula	C14H20Br2N2
Molecular Weight	376.13 g/mol
Synonyms	N-(2-Amino-3,5-dibromobenzyl)-N-methylcyclohexanamine; 2-Amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine; 3,5-Dibromo-2-[(cyclohexylmethylamino)methyl]aniline; Bromhexine Impurity F (EP); Bromhexine Related Compound F; Bromhexine EP Impurity F
EINECS	Contact for details

Quality Control

Our Bromhexine Impurity F is manufactured and tested under strict quality management systems. Each batch is characterized using advanced analytical techniques to ensure high purity and structural identity, aligning with pharmacopoeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity (by HPLC), and related substances. Our quality commitment supports compliance with ICH, USP, and EP guidelines.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

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)	Individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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