Lansoprazole

Lansoprazole: proton pump inhibitor (benzimidazole).

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

Structure

Lansoprazole: 2D structure drawn from the PubChem record (CID 3883).

Compound data

CAS number

103577-45-3

Formula

C₁₆H₁₄F₃N₃O₂S

Molecular weight

369.36 g/mol

Type

Proton pump inhibitor (benzimidazole)

Structure and names

Identity: Lansoprazole

IUPAC name: 2-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylsulfinyl]-1H-benzimidazole

How Vanguard tests Lansoprazole

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 and UV spectroscopy, assay by HPLC, organic impurities by HPLC, plus residue on ignition and water content. Full testing to the USP Lansoprazole 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

Lansoprazole (CAS 103577-45-3)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Lansoprazole 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 Lansoprazole monograph is available and quoted.

Is lansoprazole sensitive to acid and moisture?

Yes. It breaks down in acid and slowly with heat and humidity, and the breakdown products show as extra HPLC peaks. Store samples dry and tightly closed.

Can delayed-release capsules or orally disintegrating tablets be tested?

Yes. The coated granules are extracted in a basic solution to keep the lansoprazole intact, and the result is reported as percent of label claim.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/3883

Identity facts from the USP monograph header for this compound.

Order

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