Cromolyn sodium (sodium cromoglicate)

Cromolyn sodium: mast cell stabilizer (chromone).

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

Structure

Cromolyn sodium: 2D structure drawn from the PubChem record (CID 27503).

Compound data

CAS number

15826-37-6

Formula

C₂₃H₁₄Na₂O₁₁

Molecular weight

512.33 g/mol

Type

Mast cell stabilizer (chromone)

Structure and names

Identity: Cromolyn sodium

IUPAC name: disodium;5-[3-(2-carboxylato-4-oxochromen-5-yl)oxy-2-hydroxypropoxy]-4-oxochromene-2-carboxylate

How Vanguard tests Cromolyn sodium

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, HPLC retention time and a sodium test, assay by HPLC, organic impurities by HPLC, oxalate by visible spectrophotometry, water determination, and sterility where labeled sterile. Full testing to the USP Cromolyn Sodium 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

Cromolyn Sodium (CAS 15826-37-6)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Cromolyn sodium 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 Cromolyn Sodium monograph is available and quoted.

Is cromolyn sodium the same as sodium cromoglicate?

Yes. Cromolyn sodium is the US name and sodium cromoglicate is the international name for the same disodium salt.

Does cromolyn sodium absorb water?

Yes. It is hygroscopic, so water content affects the as-is assay. Keep samples sealed and tell us if you need the result on a dried basis.

What forms does cromolyn sodium arrive in?

Powder, nebulizer solutions, nasal sprays and eye drops. Solutions are diluted and assayed against the label concentration.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/27503

Identity facts from the USP monograph header for this compound.

Order

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