Loratadine

Loratadine: tricyclic antihistamine (second generation).

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

Structure

Loratadine: 2D structure drawn from the PubChem record (CID 3957).

Compound data

CAS number

79794-75-5

Formula

C₂₂H₂₃ClN₂O₂

Molecular weight

382.88 g/mol

Type

Tricyclic antihistamine (second generation)

Structure and names

Identity: Loratadine

IUPAC name: ethyl 4-(13-chloro-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-ylidene)piperidine-1-carboxylate

How Vanguard tests Loratadine

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, plus residue on ignition and loss on drying. Full testing to the USP Loratadine 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

Loratadine (CAS 79794-75-5)
Tell us the salt or form the label states, so quantity is reported on the same basis.

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

Can the test tell loratadine from desloratadine?

Yes. Desloratadine is loratadine without its ethyl carbamate group, so it is 72 mass units lighter by LC-MS and elutes at a different HPLC retention time.

Loratadine is almost insoluble in water. Does that affect testing?

Samples are dissolved in an organic solvent mix before HPLC so the full amount is recovered from tablets, capsules or syrup.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/3957

Identity facts from the USP monograph header for this compound.

Order

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