Omeprazole

Omeprazole: proton pump inhibitor (benzimidazole).

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

Structure

2D structure of Omeprazole

Omeprazole: 2D structure drawn from the PubChem record (CID 4594).

Compound data

CAS number

73590-58-6

Formula

C17H19N3O3S

Molecular weight

345.42 g/mol

Type

Proton pump inhibitor (benzimidazole)

Structure and names

Identity: Omeprazole

IUPAC name: 6-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole

How Vanguard tests Omeprazole

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 by HPLC, a visible absorbance limit for two related compounds, plus residue on ignition, completeness of solution and loss on drying. Full testing to the USP Omeprazole 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

$250

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

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on testPrice
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

  • Omeprazole (CAS 73590-58-6)
  • Omeprazole Magnesium
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Omeprazole 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 Omeprazole monograph is available and quoted.

Why does omeprazole discolor?

Omeprazole breaks down quickly in acid and slowly with heat, light and moisture, and its breakdown products are colored. Discolored powder or pellets usually show lower assay and extra impurity peaks.

Can the test tell omeprazole from esomeprazole?

Not with the standard method. Esomeprazole is the S-enantiomer of omeprazole, with the same mass and retention time, so a chiral HPLC method is needed, which is quoted separately.

Can delayed-release capsules be tested?

Yes. The enteric-coated pellets are extracted in a basic solution to protect the omeprazole, and the result is reported as percent of the label claim.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/4594

Identity facts from the USP monograph header for this compound.

Order

Start an order online, or send the compound name and the tests you need for a quote.