Calcium lactobionate

Calcium lactobionate: mineral salt (calcium).

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

Structure

Calcium lactobionate: 2D structure drawn from the PubChem record (CID 11954336).

Compound data

CAS number

110638-68-1

Formula

C₂₄H₄₂CaO₂₄ · 2H₂O

Molecular weight

790.68 g/mol

Type

Mineral salt (calcium)

Structure and names

Identity: Calcium lactobionate (dihydrate)

IUPAC name: calcium;bis((2R,3R,4R,5R)-2,3,5,6-tetrahydroxy-4-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanoate);dihydrate

How Vanguard tests Calcium lactobionate

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

The USP monograph covers identity by a calcium test, infrared spectroscopy and thin-layer chromatography, assay by complexometric titration with edetate, chloride and sulfate limit tests, reducing substances by iodometric titration, optical rotation and pH. Full testing to the USP Calcium Lactobionate 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

Calcium Lactobionate
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Calcium lactobionate testing

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

No. The $250 test covers identity, purity and quantity by ICP-MS for calcium content and a chromatographic method suited to the compound for the lactobionate part. Full testing to the USP Calcium Lactobionate monograph is available and quoted.

What is lactobionate, and what impurities can it carry?

Lactobionic acid is made by oxidizing lactose, so lactose and other sugars are possible impurities. These can show as separate peaks in the counter-ion analysis.

Why is lactobionate hard to see by UV detection?

It is a sugar acid with no aromatic ring, so the lab uses a detection method suited to the compound.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/11954336

Identity facts from the USP monograph header for this compound.

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