Nifedipine

Nifedipine: calcium channel blocker (dihydropyridine).

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

Structure

Nifedipine: 2D structure drawn from the PubChem record (CID 4485).

Compound data

CAS number

21829-25-4

Formula

C₁₇H₁₈N₂O₆

Molecular weight

346.33 g/mol

Type

Calcium channel blocker (dihydropyridine)

Structure and names

Identity: Nifedipine

IUPAC name: dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

How Vanguard tests Nifedipine

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 and HPLC retention time, assay by HPLC, organic impurities by HPLC, residue on ignition, chloride and sulfate limit tests, a perchloric acid titration limit, and loss on drying. Full testing to the USP Nifedipine 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

Nifedipine (CAS 21829-25-4)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Nifedipine 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 quantity and LC-MS for identity. Full testing to the USP Nifedipine monograph is available and quoted.

Is nifedipine light sensitive?

Yes, strongly. Under daylight or UV light nifedipine converts to its nitrosophenylpyridine and nitrophenylpyridine analogs, which are its main related compounds. Samples should be kept in amber containers and prepared under low light.

What form do nifedipine samples come in?

Nifedipine arrives as raw powder, liquid-filled capsules or extended-release tablets. Each needs its own extraction, and light protection applies to all of them.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/4485

Identity facts from the USP monograph header for this compound.

Order

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