Description

Ambroxol Hydrochloride Impurity C is a specified impurity of the active pharmaceutical ingredient Ambroxol Hydrochloride, identified by CAS No. 50910-53-7. This reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the purity and safety of the final drug product. It is an essential material for research and development laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ambroxol Hydrochloride Impurity C in drug substances and products.
• Analytical Method Development & Validation: Crucial for developing and validating HPLC, UPLC, or GC methods to monitor impurities as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to ensure Ambroxol Hydrochloride API and finished dosage forms meet stringent pharmacopoeial (e.g., USP, EP, BP) and internal specification limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., CMC sections for FDA, EMA) by providing impurity characterization and control data.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Ambroxol Hydrochloride.

Basic Information

Product Name	Ambroxol Hydrochloride Impurity C
CAS No.	50910-53-7
Molecular Formula	C13H18Br2N2O • HCl
Molecular Weight	414.01 g/mol (Free base: 378.11)
Synonyms	trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride; Ambroxol Impurity C; Ambroxol Related Compound C; Ambroxol EP Impurity C; Ambroxol Hydrochloride Related Substance C; 4-[[(2-Amino-3,5-dibromophenyl)methyl]amino]cyclohexanol Hydrochloride (trans-); ABX Imp C
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Hydrochloride Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopoeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.