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PHR1141

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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

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About This Item

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

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)

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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.

related product

Product No.
Description
Pricing

1478618

Ondansetron Related Compound C, United States Pharmacopeia (USP) Reference Standard

1478593

Ondansetron Related Compound A, United States Pharmacopeia (USP) Reference Standard

1478629

Ondansetron Related Compound D, United States Pharmacopeia (USP) Reference Standard

1478582

Ondansetron hydrochloride, United States Pharmacopeia (USP) Reference Standard

1478630

Ondansetron Resolution Mixture, United States Pharmacopeia (USP) Reference Standard

PHR1181

2-Methylimidazole (Ondansetron Impurity F), Pharmaceutical Secondary Standard; Certified Reference Material

Y0000195

Ondansetron impurity D, European Pharmacopoeia (EP) Reference Standard

Y0000196

Ondansetron for TLC system suitability, European Pharmacopoeia (EP) Reference Standard

Y0000197

Ondansetron for LC system suitability, European Pharmacopoeia (EP) Reference Standard

Y0000218

Ondansetron hydrochloride dihydrate, European Pharmacopoeia (EP) Reference Standard

Y0001326

Ondansetron impurity E, European Pharmacopoeia (EP) Reference Standard

Y0001320

Ondansetron impurity F, European Pharmacopoeia (EP) Reference Standard

Y0001346

Ondansetron impurity G, European Pharmacopoeia (EP) Reference Standard

BP808

Ondansetron hydrochloride dihydrate, British Pharmacopoeia (BP) Reference Standard

signalword

Danger

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 2 - Eye Dam. 1

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD3730
LRAC0590
LRAA7141
P500141

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Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets
Khan S, et al.
Aaps Pharmscitech, 8(2), E127-E133 (2007)
UV spectrophotometric method for determination of ondansetron hydrochloride in pure and its formulation
Kalaichelvi R,et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 4(4), 151-152 (2012)
Development of solid self-nanoemulsifying granules (SSNEGs) of ondansetron hydrochloride with enhanced bioavailability potential
Beg S, et al.
Colloids and Surfaces. B, Biointerfaces, 101(3), 414-423 (2013)
Determination of ondansetron hydrochloride by a liquid membrane potentiometric sensor based on room temperature ionic liquids
Faridbod F, et al.
International Journal of Electrochemical Science, 8(8), 10461-10472 (2013)
Fast dissolving sublingual films of ondansetron hydrochloride: effect of additives on in vitro drug release and mucosal permeation
Koland M, et al.
Journal of Young Pharmacists : Jyp, 2(3), 216-222 (2010)
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