Dalfampridine (4-aminopyridine)

Dalfampridine: potassium channel blocker (aminopyridine).

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

Structure

Dalfampridine: 2D structure drawn from the PubChem record (CID 1727).

Compound data

CAS number

504-24-5

Formula

C₅H₆N₂

Molecular weight

94.11 g/mol

Type

Potassium channel blocker (aminopyridine)

Structure and names

Identity: Dalfampridine

IUPAC name: pyridin-4-amine

How Vanguard tests Dalfampridine

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 with UV at 275 nm, related compounds B and C and organic impurities by HPLC, residue on ignition and water determination. Full testing to the USP Dalfampridine 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

Dalfampridine (CAS 504-24-5)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Dalfampridine 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 Dalfampridine monograph is available and quoted.

Is dalfampridine the same as 4-aminopyridine?

Yes. Dalfampridine is the drug name for 4-aminopyridine. Its isomers 2- and 3-aminopyridine have the same mass, so HPLC retention is used to tell them apart.

Why does dalfampridine need special HPLC conditions?

It is a small, basic and very polar molecule that elutes early on a standard C18 column, so the method uses conditions that retain polar bases.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/1727

Identity facts from the USP monograph header for this compound.

Order

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