Terbinafine hydrochloride

Terbinafine hydrochloride: allylamine antifungal.

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

Structure

2D structure of Terbinafine hydrochloride

Terbinafine hydrochloride: 2D structure drawn from the PubChem record (CID 5282481).

Compound data

CAS number

78628-80-5

Formula

C21H25N · HCl

Molecular weight

327.90 g/mol

Type

Allylamine antifungal

Structure and names

Identity: Terbinafine hydrochloride

IUPAC name: (E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine;hydrochloride

How Vanguard tests Terbinafine hydrochloride

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 a chloride test, assay by HPLC, organic impurities by HPLC, and loss on drying and residue on ignition. Full testing to the USP Terbinafine Hydrochloride 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

$250

Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on testPrice
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

  • Terbinafine
  • Terbinafine Hydrochloride (CAS 78628-80-5)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Terbinafine hydrochloride 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 Terbinafine Hydrochloride monograph is available and quoted.

Does terbinafine have geometric isomers?

Yes. Terbinafine is the E isomer, and the Z isomer is a known related compound. It shows up as a separate peak in the HPLC purity profile.

Can terbinafine creams be tested?

Yes. Creams and gels need extraction from the base before HPLC, and results are reported as a percentage by weight, as terbinafine hydrochloride unless the base is requested.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/5282481

Identity facts from the USP monograph header for this compound.

Order

Start an order online, or send the compound name and the tests you need for a quote.