Description

Bromhexine Hydrochloride Impurity Dn-(2-Amino-5-Bromobenzyl)-n-Methylcyclohexanamine Dihydrochloride is a high-purity reference standard and impurity used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Bromhexine Hydrochloride. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by enabling accurate identification, quantification, and control of related substances. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical manufacturing, contract research organizations (CROs), and regulatory testing laboratories.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Bromhexine Hydrochloride and its related substances.
• Impurity Profiling & Control: Used in method development and validation for HPLC, UPLC, and GC analyses to monitor and control specified and unspecified impurities in API batches.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Bromhexine Hydrochloride.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization data.
• Quality Control (QC) Testing: Used in routine QC laboratories to calibrate instruments and verify the accuracy of analytical methods for release testing of pharmaceutical raw materials and finished products.
• Research & Development (R&D): Supports synthetic chemistry research for process optimization and the development of new synthetic routes for Bromhexine and its analogues.

Basic Information

Product Name	Bromhexine Hydrochloride Impurity Dn-(2-Amino-5-Bromobenzyl)-n-Methylcyclohexanamine Dihydrochloride
CAS No.	132004-28-5
Molecular Formula	C20H28Br2Cl2N2
Molecular Weight	516.16 g/mol
Synonyms	Bromhexine Impurity D; Bromhexine Related Compound D; N-(2-Amino-5-bromobenzyl)-N-methylcyclohexanamine dihydrochloride; 2-[(2-Amino-5-bromophenyl)methyl-methylamino]cyclohexane dihydrochloride; Bromhexine HCl Impurity D; Bromhexine Dihydrochloride Impurity D; Cyclohexanamine, N-[(2-amino-5-bromophenyl)methyl]-N-methyl-, dihydrochloride
EINECS	Contact for details

Quality Control

Our Bromhexine Hydrochloride Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, including retention time and relative response factor where applicable. Our quality commitment aligns with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

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) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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