Description

Ambroxol Ep Impurity B CAS NO 18683-95-9 is a high-purity reference standard 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) Ambroxol. It is an essential tool for researchers and quality control professionals in the pharmaceutical industry who require precise identification and quantification of related substances. Its use is fundamental in method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ambroxol-related impurities in compliance with ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control analysis to ensure Ambroxol API and finished drug products meet specified purity limits.
• Stability Studies: Employed to monitor the formation of degradation products in Ambroxol formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports testing procedures as per USP, EP, BP, and other international pharmacopoeia standards for Ambroxol.

Basic Information

Item	Detail
Product Name	Ambroxol Ep Impurity B
CAS No.	18683-95-9
Molecular Formula	C13H18Br2N2O
Molecular Weight	378.10 g/mol
Synonyms	trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol; Ambroxol Impurity B; Ambroxol Related Compound B; Ambroxol EP Impurity B; Ambroxol USP Impurity B; Ambroxol Hydrochloride Impurity B; 4-[[(2-Amino-3,5-dibromophenyl)methyl]amino]cyclohexanol (trans-isomer)
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopoeial standards (EP, USP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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