Description

Bromhexine Impurity H is a high-purity reference standard and a key process-related impurity in the synthesis of the active pharmaceutical ingredient Bromhexine Hydrochloride. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in research, development, and regulatory compliance for respiratory medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bromhexine Impurity H in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during API synthesis and stability studies.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the purity and consistency of Bromhexine Hydrochloride batches.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documents (e.g., ICH guidelines, FDA/EMA submissions) by providing characterized impurity profiles.
• Process Chemistry Research: Used in route scouting and process optimization studies to understand and minimize the formation of this specific impurity.
• Stability Testing: Employed in forced degradation studies to identify and track impurity formation under various stress conditions (e.g., heat, light, humidity).

Basic Information

Product Name	Bromhexine Impurity H
CAS No.	63471-27-2
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-methylbenzenemethanamine; Bromhexine Impurity H (EP); Bromhexine Related Compound H; Bromhexine EP Impurity H; 3,5-Dibromo-2-[(cyclohexylmethylamino)methyl]aniline; UNII-1L8K3F3K1P
EINECS	Contact for details

Quality Control

Our Bromhexine Impurity H is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with pharmacopeial standards (EP, USP).

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	≤ 1.0% w/w

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