Mesalamine (5-aminosalicylic acid)

Mesalamine: aminosalicylate.

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

Structure

Mesalamine: 2D structure drawn from the PubChem record (CID 4075).

Compound data

CAS number

89-57-6

Formula

C₇H₇NO₃

Molecular weight

153.14 g/mol

Type

Aminosalicylate

Structure and names

Identity: Mesalamine

IUPAC name: 5-amino-2-hydroxybenzoic acid

How Vanguard tests Mesalamine

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 by HPLC, a volatile impurity limit by GC, chloride, sulfate, hydrogen sulfide and sulfur dioxide tests, residue on ignition, clarity of solution, loss on drying, and pH. Full testing to the USP Mesalamine 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

Mesalamine (CAS 89-57-6)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Mesalamine 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 quantity and LC-MS for identity. Full testing to the USP Mesalamine monograph is available and quoted.

Can the test tell mesalamine from 4-aminosalicylic acid?

Yes. The two are positional isomers with the same mass, so they are told apart by HPLC retention time. 4-Aminosalicylic acid is a known related compound.

Does mesalamine discolor?

Mesalamine is an aminophenol and oxidizes in air and light, turning pink to brown. Oxidation products appear in the HPLC purity profile, so samples should be kept closed and dark.

Why is GC part of the USP monograph?

The monograph uses GC to control a volatile impurity that HPLC alone does not cover well. That test is part of full monograph testing.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/4075

Identity facts from the USP monograph header for this compound.

Order

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