Description

Ambroxol Impurity 15 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 and efficacy of the active pharmaceutical ingredient (API) Ambroxol by accurately identifying and quantifying related substances. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and production. The compound is supplied with comprehensive analytical data to support regulatory filings and internal quality protocols.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ambroxol API and finished dosage forms.
• Method Development & Validation: Critical for developing and validating analytical methods, particularly HPLC and UPLC, to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Batch Release: Used in routine QC testing of Ambroxol raw materials and drug products to ensure compliance with pharmacopoeial limits (e.g., USP, EP, BP).
• Stability Studies: Employed to monitor the formation of degradation products in Ambroxol formulations under various stress conditions (ICH Q1A).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this specific impurity during Ambroxol synthesis.

Basic Information

Product Name	Ambroxol Impurity 15
CAS No.	2380794-49-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ambroxol Related Compound 15; Ambroxol EP Impurity J; Ambroxol USP Impurity; trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol (proposed); Ambroxol Degradant; Ambroxol Process Impurity; Ambroxol Isomer; ABX Impurity 15
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Impurity 15 is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and 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). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.