Oseltamivir phosphate

Oseltamivir phosphate: antiviral (neuraminidase inhibitor).

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

Structure

Oseltamivir phosphate: 2D structure drawn from the PubChem record (CID 78000).

Compound data

CAS number

204255-11-8

Formula

C₁₆H₂₈N₂O₄ · H₃PO₄

Molecular weight

410.40 g/mol

Type

Antiviral (neuraminidase inhibitor)

Structure and names

Identity: Oseltamivir phosphate

IUPAC name: ethyl (3R,4R,5S)-4-acetamido-5-amino-3-pentan-3-yloxycyclohexene-1-carboxylate;phosphoric acid

How Vanguard tests Oseltamivir phosphate

Method for the $250 identity, purity and quantity test: Chromatographic assay, with detection selected for the compound, 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, impurities by chromatography, optical rotation, and water content. Full testing to the USP Oseltamivir Phosphate 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

Oseltamivir Phosphate (CAS 204255-11-8)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Oseltamivir phosphate testing

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

No. The $250 test covers identity, purity and quantity by a chromatographic assay, with detection selected for the compound. Full testing to the USP Oseltamivir Phosphate monograph is available and quoted.

What does the ester group mean for oseltamivir stability?

Oseltamivir is an ethyl ester, and it hydrolyzes to oseltamivir carboxylate in water. The carboxylate is a separate HPLC peak and is 28 mass units lighter.

Why is oseltamivir hard to detect by UV?

Oseltamivir absorbs UV only weakly, at low wavelengths, so the lab uses a detection method suited to the compound.

Is the result reported as the phosphate salt?

Raw material and capsule contents are oseltamivir phosphate. Results can be stated as the salt or as oseltamivir base using the molecular weights.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/78000

Identity facts from the USP monograph header for this compound.

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