Diclofenac (sodium and potassium salts)

Diclofenac: nSAID (phenylacetic acid derivative).

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

Structure

Diclofenac: 2D structure drawn from the PubChem record (CID 5018304).

Compound data

CAS number

15307-79-6

Formula

C₁₄H₁₀Cl₂NNaO₂

Molecular weight

318.13 g/mol

Type

NSAID (phenylacetic acid derivative)

Structure and names

Identity: Diclofenac sodium

IUPAC name: sodium 2-[2-(2,6-dichloroanilino)phenyl]acetate

How Vanguard tests Diclofenac

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 flame test, assay by potentiometric titration, organic impurities by HPLC, and color, clarity, pH and loss on drying. Full testing to the USP Diclofenac 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

Diclofenac Sodium (CAS 15307-79-6)
Diclofenac Potassium
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Diclofenac 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 Diclofenac Sodium monograph is available and quoted.

Does it matter whether the sample is diclofenac sodium or diclofenac potassium?

Yes. The two salts have different molecular weights, so the same mass gives a different amount of diclofenac. Tell us which salt is on the label so the assay is calculated against the right form.

What degradation product is checked in diclofenac?

Diclofenac can cyclize to a lactam, 1-(2,6-dichlorophenyl)indolin-2-one, listed in USP as diclofenac related compound A. It shows up as a separate peak in the HPLC purity profile.

Can diclofenac gels be tested?

Yes. Topical gels need an extraction step to separate diclofenac from the gel base before HPLC, and the result is reported as a percentage by weight.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/5018304

Identity facts from the USP monograph header for this compound.

Order

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