Prednisolone

Prednisolone: corticosteroid (glucocorticoid).

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

Structure

2D structure of Prednisolone

Prednisolone: 2D structure drawn from the PubChem record (CID 5755).

Compound data

CAS number

50-24-8

Formula

C21H28O5

Molecular weight

360.44 g/mol

Type

Corticosteroid (glucocorticoid)

Structure and names

Identity: Prednisolone (anhydrous)

IUPAC name: (8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one

How Vanguard tests Prednisolone

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, chromatographic purity by HPLC, specific rotation, loss on drying, residue on ignition and a selenium limit. Full testing to the USP Prednisolone 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

  • Prednisolone (CAS 50-24-8; sesquihydrate CAS 52438-85-4)
  • Prednisolone Acetate
  • Prednisolone Sodium Phosphate
  • Prednisolone Tebutate (CAS 7681-14-3)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Prednisolone testing

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

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

Prednisolone can be anhydrous or a sesquihydrate. Does it matter?

Yes. The sesquihydrate holds water of crystallization, so its assay on an as-is basis is lower than the anhydrous form. Tell us which form is on the label.

Why does the USP monograph include a selenium limit?

Some synthesis routes use selenium reagents to form the double bond in ring A. The limit checks that none is carried into the final material.

Can you test prednisolone acetate eye drops or suspensions?

Yes. Suspensions are mixed, sampled by weight and dissolved before HPLC. Send the labeled concentration so the result can be compared.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/5755

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.