Description

Ambroxol Impurity 19 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Ambroxol HCl. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Ambroxol HCl bulk drug and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing in pharmaceutical manufacturing to monitor and control impurity levels.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Ambroxol formulations.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of Ambroxol.

Basic Information

Product Name	Ambroxol Impurity 19
CAS No.	1631131-54-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ambroxol Related Compound 19; Ambroxol EP Impurity 19; Ambroxol USP Impurity 19; Ambroxol Process Impurity; trans-4-((6,8-Dibromo-3a,4,5,6,7,7a-hexahydro-1H-benzo[d]imidazol-2-yl)amino)cyclohexan-1-ol (proposed); Ambroxol Impurity D (potential); Ambroxol Degradant; Bromhexine Metabolite VIII Impurity
EINECS	Contact for details

Quality Control

Every batch of Ambroxol Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic and spectroscopic techniques (HPLC, GC, MS, NMR) to ensure compliance with pharmacopeial standards. 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) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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