CAS 23828-92-4 Ambroxol hydrochloride - Analytical Products / Alfa Chemistry

CAT	APS23828924
CAS	23828-92-4
Structure
MDL Number	MFCD00078932
Synonyms	Fluibron, Fluixol,Cyclohexanol, 4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-, hydrochloride (1:1), trans-, Coughnol, Mucasan, Mucosolvan, Pect, Mucoclear, Ambrodil, Solvolan, Mucolear, Mucolite, Surbronc, Cyclohexanol, 4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-, monohydrochloride, trans- (9CI), Frenopect, trans-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, Mucofar, Lindoxyl, Bronchopront, Abramen, Ambril, Motosol, Mucovent, Cyclohexanol, 4-[(2-amino-3,5-dibromobenzyl)amino]-, hydrochloride, trans- (8CI), Muco-Burg, Surfactal, Stas-Hustenloser, Mucolin, N-(trans-4-Hydroxycyclohexyl)-2-amino-3,5-dibromobenzylamine hydrochloride, Ambron, Ambroxol hydrochloride, Mucosal, Duramucal
IUPAC Name	4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;hydrochloride
Molecular Weight	414.56
Molecular Formula	C13H18Br2N2O.ClH
EC Number	245-899-2
Canonical SMILES	Cl.Nc1c(Br)cc(Br)cc1CN[C@@H]2CC[C@@H](O)CC2
InChI	InChI=1S/C13H18Br2N2O.ClH/c14-9-5-8(13(16)12(15)6-9)7-17-10-1-3-11(18)4-2-10
InChI Key	QNVKOSLOVOTXKF-PFWPSKEQSA-N

Description	analytical standard
Accurate Mass	411.9553
Form	neat; gas chromatography (GC): suitable
Format	Neat
Grade	analytical standard
Size	5G
Storage Conditions	2-8°C

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CAT	Size	Shipping	Storage Conditions	Description	Price
APS23828924-100MG	100MG	Room Temperature	+4°C	Subcategory: Pharmaceutical and veterinary compounds and metabolites	Inquiry
APS23828924-125MG	125MG	Room Temperature	2-8°C Fridge/Coldroom	API Family: Matrix - API Family See respective official monograph(s); Product Type: API; Subcategory: European Pharmacopoeia (Ph. Eur.)	Inquiry
APS23828924-250MG	250MG	Room Temperature	+5°C	API Family: Matrix - API Family Ambroxol Hydrochloride; Product Type: API; Subcategory: Respiratory drugs, API standards, Mikromol	Inquiry

Case Study

Pharmaceutical Grade Ambroxol Hydrochloride (ABH) for Simultaneous Quantification with Levocetirizine Dihydrochloride in Tablet Formulations

Ali, Omnia IM, Nahla S. Ismail, and Rasha M. Elgohary. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 153 (2016): 605-611.

A precise and accurate method was developed for the simultaneous determination of Ambroxol Hydrochloride (ABH) and Levocetirizine Dihydrochloride (LCD) in pharmaceutical tablet formulations using derivative spectrophotometry. The experimental process was conducted using three derivative spectrophotometric techniques, including the first and second derivative spectrophotometry, as well as the first derivative of ratio spectra.
The preparation of standard solutions began by dissolving 100 mg of ABH and LCD in methanol, creating stock solutions at 1 mg mL-1 concentrations. Working solutions were then prepared by diluting the stock solutions to achieve concentration ranges of 4.0-20.0 μg mL-1 for ABH. All solutions were kept stable at 4°C for up to three days. Tablet samples were accurately weighed, powdered, and dissolved in 70 mL of methanol. The solution was sonicated for 15 minutes to ensure complete dissolution, followed by filtration and dilution to the required concentration range for analysis.
In the first derivative spectrophotometric method, measurements were performed at 220.0 nm for ABH, using the zero-crossing technique. The second derivative method utilized 224.4 nm for ABH, while the ratio derivative method involved measurements at 247.2 nm. These methods allowed for effective separation and quantification of both drugs, ensuring reliable analysis in commercial tablet formulations.

Ambroxol Hydrochloride Standard Solutions for Raman Spectroscopy-Based Quantification in Commercial Injections

Le, Jian, et al. Analytical Methods 6.4 (2014): 1096-1100.

Ambroxol Hydrochloride (AML) standard solutions are crucial for the accurate quantification of AML in pharmaceutical formulations, particularly in commercial injections, where its concentration is often less than 1% (w/v). A novel approach combining Raman spectroscopy with chemometric techniques has been developed for the quantitative determination of AML in such injections. Standard AML solutions were first used to create calibration models employing various spectral treatment methods, including classical least squares (CLS), partial least squares (PLS), principal component regression (PCR), and stepwise multiple linear regression (SMLR).
The study demonstrated that both the CLS and PCR models provided highly effective predictions, with minimal differences (94.9% and 94.2%, respectively), and low root mean square errors (RMSEs) of 0.07 and 0.08. The predictive accuracy of the developed models was validated by direct application to eleven commercial AML injections. When compared with the pharmacopoeial HPLC method, no significant difference in results was observed (p > 0.05), confirming the reliability and accuracy of the Raman-based method.
This work highlights the importance of AML standard solutions in developing an efficient, non-invasive, and rapid alternative for the quantification of AML in pharmaceutical products. The proposed procedure, based on Raman spectroscopy and chemometrics, offers a promising method for quality control, replacing more traditional compendial techniques.

Ambroxol Hydrochloride (AML) Application in Drug Substance Analysis and Impurity Profiling Using Liquid Chromatography

Rao, K. Lakshmi Narasimha, et al. Journal of Saudi Chemical Society 18.5 (2014): 593-600.

Ambroxol Hydrochloride (AML) is widely used in pharmaceutical formulations as a mucolytic agent for respiratory conditions. A recent study developed a precise liquid chromatographic method for the detection of AML and its potential impurities in drug substances and products. The method, utilizing an X-Terra RP-18 column and a gradient mobile phase, efficiently separates AML from its associated impurities, enabling accurate impurity profiling at concentrations as low as 0.015%.
In this application, stock solutions of AML were prepared, and its concentration in the syrup samples was analyzed through a UV detection method at 222 nm. This approach not only ensures the accurate quantification of AML but also facilitates the assessment of impurity levels, critical for maintaining the safety and efficacy of pharmaceutical products. The method demonstrated excellent precision with inter-day and intra-day precision (% RSD) under 3.0%, making it highly reliable for routine quality control in pharmaceutical industries.
Additionally, the study subjected AML-containing formulations to various stress conditions such as acid, base, oxidation, and thermal degradation, as per ICH guidelines, further emphasizing AML's role in stability testing. This reliable and efficient method for AML detection highlights its key application in ensuring the quality, safety, and consistency of drug products.