Lamotrigine

Lamotrigine: phenyltriazine anticonvulsant.

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

Structure

Lamotrigine: 2D structure drawn from the PubChem record (CID 3878).

Compound data

CAS number

84057-84-1

Formula

C₉H₇Cl₂N₅

Molecular weight

256.09 g/mol

Type

Phenyltriazine anticonvulsant

Structure and names

Identity: Lamotrigine

IUPAC name: 6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine

How Vanguard tests Lamotrigine

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, a named related compound and organic impurities by HPLC, plus residue on ignition and loss on drying. Full testing to the USP Lamotrigine 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

Lamotrigine (CAS 84057-84-1)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Lamotrigine 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 Lamotrigine monograph is available and quoted.

Lamotrigine is not very soluble in water. Does that affect testing?

Samples are dissolved in an acidified or organic solvent mix before HPLC so the whole amount is recovered. This applies to powder and to tablets alike.

Can chewable, dispersible or extended-release tablets be tested?

Yes. Each tablet type is ground and fully extracted, and the result is reported as percent of the label claim.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/3878

Identity facts from the USP monograph header for this compound.

Order

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