Ferrous gluconate

Ferrous gluconate: mineral salt (iron).

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

Structure

Ferrous gluconate: 2D structure drawn from the PubChem record (CID 71372).

Compound data

CAS number

12389-15-0

Formula

C₁₂H₂₂FeO₁₄ · 2H₂O

Molecular weight

482.17 g/mol

Type

Mineral salt (iron)

Structure and names

Identity: Ferrous gluconate dihydrate

IUPAC name: iron(2+);bis(2,3,4,5,6-pentahydroxyhexanoate);dihydrate

How Vanguard tests Ferrous gluconate

Method for the $250 identity, purity and quantity test: ICP-MS metal content, HPLC assay of the gluconate counter-ion, against a reference standard, with results in 3 to 5 business days.

The USP monograph covers identity by TLC and a ferrous ion test, assay by titration, ferric iron by titration, chloride, sulfate, mercury, arsenic and lead limits, oxalic acid, reducing sugars, and loss on drying. Full testing to the USP Ferrous Gluconate monograph is available and quoted.

What's reported

Metal content by ICP-MS, against the label or specification
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

Ferrous Gluconate (anhydrous CAS 299-29-6; dihydrate CAS 12389-15-0)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Ferrous gluconate testing

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

No. The $250 test covers identity, purity and quantity by ICP-MS for iron and HPLC for the gluconate. Full testing to the USP Ferrous Gluconate monograph is available and quoted.

Does ferrous gluconate oxidize?

Yes. Ferrous iron slowly oxidizes to ferric iron in air and moisture. ICP-MS gives total iron, and the ferric fraction needs a separate titration.

Why are oxalic acid and reducing sugars tested?

They are leftovers or by-products from making gluconate from glucose. The USP monograph limits both.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/71372

Identity facts from the USP monograph header for this compound.

Order

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