Topiramate

Topiramate: sulfamate-substituted monosaccharide anticonvulsant.

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

Structure

Topiramate: 2D structure drawn from the PubChem record (CID 5284627).

Compound data

CAS number

97240-79-4

Formula

C₁₂H₂₁NO₈S

Molecular weight

339.36 g/mol

Type

Sulfamate-substituted monosaccharide anticonvulsant

Structure and names

Identity: Topiramate

IUPAC name: [(1R,2S,6S,9R)-4,4,11,11-tetramethyl-3,5,7,10,12-pentaoxatricyclo[7.3.0.02,6]dodecan-6-yl]methyl sulfamate

How Vanguard tests Topiramate

Method for the $250 identity, purity and quantity test: Chromatographic assay, with detection selected for the compound, 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, sulfamate and sulfate by ion chromatography, organic impurities by thin-layer chromatography and HPLC, plus residue on ignition, optical rotation and water content. Full testing to the USP Topiramate 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

Topiramate (CAS 97240-79-4)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Topiramate testing

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

No. The $250 test covers identity, purity and quantity by a chromatographic assay, with detection selected for the compound. Full testing to the USP Topiramate monograph is available and quoted.

Why doesn't topiramate use a standard UV detector?

Topiramate has almost no UV absorbance, so the lab uses a detection method suited to the compound.

What are the sulfamate and sulfate tests for?

Topiramate can break down and release sulfamate and sulfate ions, so the monograph measures them by ion chromatography as a check on degradation.

What sample forms are usually tested?

Powder, tablets and sprinkle capsules. The capsule beads or ground tablets are extracted and the result is reported as percent of label claim.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/5284627

Identity facts from the USP monograph header for this compound.

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