Miconazole (and miconazole nitrate)

Miconazole: imidazole antifungal.

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

Structure

Miconazole: 2D structure drawn from the PubChem record (CID 4189).

Compound data

CAS number

22916-47-8

Formula

C₁₈H₁₄Cl₄N₂O

Molecular weight

416.13 g/mol

Type

Imidazole antifungal

Structure and names

Identity: Miconazole

IUPAC name: 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole

How Vanguard tests Miconazole

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 and UV spectroscopy, assay by titration, impurities by TLC, and loss on drying and residue on ignition. Full testing to the USP Miconazole 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

Miconazole (CAS 22916-47-8)
Miconazole Nitrate
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Miconazole 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 Miconazole monograph is available and quoted.

Is the sample miconazole or miconazole nitrate?

Most creams and powders use miconazole nitrate, which weighs about 15% more than the base. Results are reported against the labeled form.

Why HPLC instead of the monograph's titration and TLC?

Titration and TLC do not give a numeric impurity profile. HPLC separates miconazole from related azole compounds and gives purity and quantity in one run.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/4189

Identity facts from the USP monograph header for this compound.

Order

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