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PHR2063

Supelco

Ambroxol Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Ambroxol hydrochloride, 2-Amino-3,5-dibromo-N-(trans-4-hydroxycyclohexyl)benzylamine

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About This Item

Empirical Formula (Hill Notation):
C13H18Br2N2O · HCl
CAS Number:
Molecular Weight:
414.56
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to Ph. Eur. A0363700

API family

ambroxol

CofA

current certificate can be downloaded

application(s)

pharmaceutical small molecule

format

neat

storage temp.

2-8°C

SMILES string

Cl.Nc1c(Br)cc(Br)cc1CN[C@@H]2CC[C@@H](O)CC2

InChI

1S/C13H18Br2N2O.ClH/c14-9-5-8(13(16)12(15)6-9)7-17-10-1-3-11(18)4-2-10;/h5-6,10-11,17-18H,1-4,7,16H2;1H/t10-,11-;

InChI key

QNVKOSLOVOTXKF-PFWPSKEQSA-N

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General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Ambroxol hydrochloride is a mucolytic expectorant. It is a metabolite of bromhexine. It stimulates the transportation of viscous secretions in the respiratory organs and reduces the accumulation of the secretions.

Application

Ambroxol Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical dosage forms by high performance liquid chromatography and sequential injection chromatography.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB8553 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

related product

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Sequential injection chromatographic determination of ambroxol hydrochloride and doxycycline in pharmaceutical preparations.
Satinsky D, et al.
Talanta, 68(2), 214-218 (2005)
Determination of ambroxol hydrochloride, methylparaben and benzoic acid in pharmaceutical preparations based on sequential injection technique coupled with monolithic column
Satinsky D, et al.
Journal of Pharmaceutical and Biomedical Analysis, 40(2), 287-293 (2006)
Quantitative determination of levofloxacin and ambroxol hydrochloride in pharmaceutical dosage form by reversed-phase high performance liquid chromatography.
Kothekar M K, et al.
Eurasian Journal of Analytical Chemistry, 2(1), 21-31 (2007)

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