Rivastigmine

Rivastigmine: cholinesterase inhibitor (carbamate).

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

Structure

Rivastigmine: 2D structure drawn from the PubChem record (CID 77991).

Compound data

CAS number

123441-03-2

Formula

C₁₄H₂₂N₂O₂

Molecular weight

250.34 g/mol

Type

Cholinesterase inhibitor (carbamate)

Structure and names

Identity: Rivastigmine

IUPAC name: [3-[(1S)-1-(dimethylamino)ethyl]phenyl] N-ethyl-N-methylcarbamate

How Vanguard tests Rivastigmine

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 and enantiomeric purity by HPLC, and water and residue on ignition. Full testing to the USP Rivastigmine 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

Rivastigmine (CAS 123441-03-2)
Rivastigmine Tartrate (CAS 129101-54-8)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Rivastigmine 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 Rivastigmine monograph is available and quoted.

Is rivastigmine tested as the base or the tartrate?

Rivastigmine base is an oily liquid used in transdermal patches, while the hydrogen tartrate is a powder used in capsules. The tartrate weighs about 60% more per mole, so results are reported against the labeled form.

Is rivastigmine a single enantiomer?

Yes, it is the S enantiomer. The monograph checks the R enantiomer by chiral HPLC, which the $250 test does not include, so chiral testing is quoted separately.

Can rivastigmine patches be tested?

Yes. The drug is extracted from the patch adhesive and reported per patch.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/77991

Identity facts from the USP monograph header for this compound.

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