Clocortolone pivalate

Clocortolone pivalate: corticosteroid (21-pivalate ester).

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

Structure

Clocortolone pivalate: 2D structure drawn from the PubChem record (CID 5282493).

Compound data

CAS number

34097-16-0

Formula

C₂₇H₃₆ClFO₅

Molecular weight

495.03 g/mol

Type

Corticosteroid (21-pivalate ester)

Structure and names

Identity: Clocortolone pivalate

IUPAC name: [2-[(6S,8S,9R,10S,11S,13S,14S,16R,17S)-9-chloro-6-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-7,8,11,12,14,15,16,17-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] 2,2-dimethylpropanoate

How Vanguard tests Clocortolone pivalate

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, and optical rotation, loss on drying and residue on ignition. Full testing to the USP Clocortolone Pivalate 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

Clocortolone Pivalate (CAS 34097-16-0)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Clocortolone pivalate 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, with LC-MS to confirm identity. Full testing to the USP Clocortolone Pivalate monograph is available and quoted.

Is clocortolone pivalate the same as clocortolone?

No. It is the 21-pivalate ester, with a higher molecular weight than free clocortolone. Ester hydrolysis releases clocortolone, which separates in the HPLC purity profile.

What form does clocortolone pivalate usually arrive in?

Powder or a topical cream. Creams are extracted before HPLC and the result is reported as a percentage by weight.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/5282493

Identity facts from the USP monograph header for this compound.

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