Ondansetron

Ondansetron: 5-HT3 receptor antagonist antiemetic.

Ondansetron testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.

Structure

Ondansetron: 2D structure drawn from the PubChem record (CID 4595).

Compound data

CAS number

99614-02-5

Formula

C₁₈H₁₉N₃O

Molecular weight

293.36 g/mol

Type

5-HT3 receptor antagonist antiemetic

Structure and names

Identity: Ondansetron

IUPAC name: 9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1H-carbazol-4-one

How Vanguard tests Ondansetron

Method for the $250 identity, purity and quantity test: HPLC-UV purity and assay, LC-MS identity, against a reference standard, with results in 3 to 5 business days.

The USP monograph covers identity by infrared spectroscopy and HPLC retention time, assay by HPLC, organic impurities and methylene bisondansetron by HPLC, plus residue on ignition, chloride, water content, bacterial endotoxins and microbial enumeration. Full testing to the USP Ondansetron monograph is available and quoted.

What's reported

Purity, as percent of total peak area
Quantity, against the label claim
Identity, reported as match or no match against the reference standard
With monograph testing (quoted): the monograph’s tests against its limits

Tests and prices

Purity and quantity

$250

Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.

Raw powder purity

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on test	Price
Identity and impurities
FTIR identity	$90
CHNS elemental analysis (carbon, hydrogen, nitrogen, sulfur)	$125
Chiral purity (where a chiral method exists; new methods quoted)	$250
Water, solvents and salt form
Water content by Karl Fischer	$60
Residual solvents	$150
Counterions: chloride, acetate and TFA	$70
Assay
Assay, % w/w (with raw powder purity; $250 together)	+$50
Metals and conformity
Heavy metals: arsenic, cadmium, chromium, mercury and lead	$150
Conformity: purity and quantity on more units from the same lot	$100 per extra unit
Microbiology (injectables)
Endotoxin	$210
Sterility or bioburden	$150
Container closure integrity (CCI)	$50
Screening
Fentanyl screen	$50

10% off for 10 or more samples.

Need something else? Other tests are available on request.

Sample amount and turnaround

Purity and quantity is $250 per sample (1 unit) and raw powder purity is $200 for 50 mg, with results in 3 to 5 business days. Send the material sealed and labeled, with the label claim and the form it contains.

Salts, forms and compendial references

Ondansetron (CAS 99614-02-5)
Ondansetron Hydrochloride
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Ondansetron testing

Is the $250 test the same as USP monograph testing?

No. The $250 test covers identity, purity and quantity by HPLC-UV for purity and assay and LC-MS for identity. Full testing to the USP Ondansetron monograph is available and quoted.

Is my sample ondansetron base or ondansetron hydrochloride?

Orally disintegrating tablets often use the base, while regular tablets and injections usually use the hydrochloride dihydrate. Label claims are normally stated as ondansetron base, so tell us the form and the result is converted correctly.

What is methylene bisondansetron?

It is a dimer impurity, two ondansetron units joined by a methylene bridge, that can form during manufacture. The monograph controls it with its own HPLC limit.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/4595

Identity facts from the USP monograph header for this compound.

Order

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