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Ondansetron Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: 1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one hydrochloride, GR 38032F, Ondansetron hydrochloride dihydrate

  • CAS Number 103639-04-9

  • Empirical Formula (Hill Notation) C18H19N3O · HCl · 2H2O

  • Molecular Weight 365.85

  •  MDL number MFCD00374371

  •  PubChem Substance ID 329823161

  •  NACRES NA.24

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Properties

Related Categories Analytical Standards, Analytical/Chromatography, K-O, Pharmaceutical Secondary Standards, Pharmacopeia & Metrological Institutes Standards More...
Quality Level   300
grade   certified reference material
  pharmaceutical secondary standard
form   neat
application(s)   HPLC: suitable
  gas chromatography (GC): suitable
Featured Industry   Pharmaceutical (small molecule)
format   neat
pharmacopeia traceability   BP
  traceable to PhEur Y0000218
  traceable to USP 1478582
SMILES string   Cl[H].[H]O[H].[H]O[H].Cc1nccn1CC2CCc3c(C2=O)c4ccccc4n3C
InChI   1S/C18H19N3O.ClH.2H2O/c1-12-19-9-10-21(12)11-13-7-8-16-17(18(13)22)14-5-3-4-6-15(14)20(16)2;;;/h3-6,9-10,13H,7-8,11H2,1-2H3;1H;2*1H2
InChI key   VRSLTNZJOUZKLX-UHFFFAOYSA-N
Gene Information   human ... HTR3A(3359)

Description

General description

Ondansetron Hydrochloride acts as a 5HT3 (serotonin) antagonist and is a powerful antiemetic drug. It is widely used for the prevention and treatment of nausea and vomiting related to post-operative states, cancer chemotherapy and radiotherapy, and chronic medical illness. It has been found to exhibit inconsistent bioavailability resulting from its poor aqueous solubility and high first-pass hepatic metabolism.
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.

Application

Ondansetron Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and combined dosage forms by spectrophotometric, electrochemical, and chromatographic techniques.

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.

Biochem/physiol Actions

5-HT3 serotonin receptor antagonist

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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.

Values of analytes vary lot to lot.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA7141 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety & Documentation

Safety Information

Symbol 
Signal word 
Danger
Hazard statements 
RIDADR 
UN 2811 6.1 / PGIII
WGK Germany 
WGK 3
Flash Point(F) 
Not applicable
Flash Point(C) 
Not applicable

Documents

Certificate of Analysis (COA)

Please Enter a Lot Number
Protocols & Articles
Peer-Reviewed Papers
15

References

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