PHR1141

Ondansetron Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Ondansetron hydrochloride dihydrate, 1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one hydrochloride, GR 38032F
• Empirical Formula (Hill Notation): C₁₈H₁₉N₃O · HCl · 2H₂O
• CAS Number: 103639-04-9
• Molecular Weight: 365.85
• MDL number: MFCD00374371
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823161
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP; traceable to Ph. Eur. Y0000218; traceable to USP 1478582
• API family: ondansetron
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• 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 Information

• Pictograms: GHS05,GHS06,GHS09
• Signal Word: Danger
• Hazard Statements: H301 - H318 - H410
• Precautionary Statements: P264 - P273 - P280 - P301 + P310 - P305 + P351 + P338 - P391
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 2 - Eye Dam. 1
• Storage Class Code: 6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable