PHR2063

Ambroxol Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Ambroxol hydrochloride, 2-Amino-3,5-dibromo-N-(trans-4-hydroxycyclohexyl)benzylamine
• Empirical Formula (Hill Notation): C₁₃H₁₈Br₂N₂O · HCl
• CAS Number: 23828-92-4
• Molecular Weight: 414.56
• MDL number: MFCD00078932
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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

Description

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

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Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable