Alprostadil (prostaglandin E1)

Alprostadil: prostaglandin (PGE1).

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

Structure

Alprostadil: 2D structure drawn from the PubChem record (CID 5280723).

Compound data

CAS number

745-65-3

Formula

C₂₀H₃₄O₅

Molecular weight

354.48 g/mol

Type

Prostaglandin (PGE1)

Structure and names

Identity: Alprostadil

IUPAC name: 7-[(1R,2R,3R)-3-hydroxy-2-[(E,3S)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]heptanoic acid

How Vanguard tests Alprostadil

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, assay by HPLC, foreign prostaglandins by HPLC, chromium and rhodium limits by atomic absorption, and residue on ignition and water. Full testing to the USP Alprostadil 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

Alprostadil (CAS 745-65-3)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Alprostadil 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 Alprostadil monograph is available and quoted.

Is alprostadil stable at room temperature?

Alprostadil is heat sensitive. It dehydrates to prostaglandin A1, which can isomerize to prostaglandin B1, so samples should ship cold, and the HPLC purity profile shows these products if present.

How is alprostadil detected without a strong UV signal?

Alprostadil has no strong UV chromophore, so it is detected at low UV wavelength, and LC-MS confirms identity by mass.

What forms does alprostadil arrive in?

Usually lyophilized powder in vials or compounded injectable solutions at low concentration, so state the labeled amount when submitting.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/5280723

Identity facts from the USP monograph header for this compound.

Order

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