Ondansetron Hydrochloride
SIAL/PHR1141 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: Ondansetron hydrochloride dihydrate; 1,2,3,9-
CAS Number: 103639-04-9
Empirical Formula (Hill Notation): C18H19N3O · HCl · 2H2O
Molecular Weight: 365.85
MDL Number: MFCD00374371
Linear Formula: C18H19N3O · HCl · 2H2O
Product Type: Chemical
| agency | traceable to BP |
| traceable to Ph. Eur. Y0000218 | |
| traceable to USP 1478582 | |
| API family | ondansetron |
| application(s) | pharmaceutical (small molecule) |
| CofA | current certificate can be downloaded |
| format | neat |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C18H19N3O.ClH.2H2O/c1- |
| InChI key | VRSLTNZJOUZKLX-UHFFFAOYSA |
| Quality Level | 300  |
| SMILES string | Cl[H].[H]O[H].[H]O[H].Cc1 |
| storage temp. | 2-30°C |
| technique(s) | gas chromatography (GC): suitable |
| HPLC: suitable |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available. |
| 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. |
| Application: | 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 |
| 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. |
| 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. |
| 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. |
| Other Notes: | Values of analytes vary lot to lot. |
| Symbol |    GHS05,GHS06,GHS09 |
| Signal word | Danger |
| Hazard statements | H301 - H318 - H410 |
| Precautionary statements | P273 - P280 - P301 + P310 + P330 - P305 + P351 + P338 + P310 |
| Hazard Codes | T |
| Risk Statements | 25-41-50/53 |
| Safety Statements | 26-39-45-61 |
| RIDADR | UN 2811 6.1 / PGIII |
| WGK Germany | WGK 3 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | 2-30°C |
| UNSPSC | 41116107 |