Duloxetine hydrochloride

Duloxetine hydrochloride: serotonin and norepinephrine reuptake inhibitor (SNRI).

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

Structure

2D structure of Duloxetine hydrochloride

Duloxetine hydrochloride: 2D structure drawn from the PubChem record (CID 60834).

Compound data

CAS number

136434-34-9

Formula

C18H19NOS · HCl

Molecular weight

333.88 g/mol

Type

Serotonin and norepinephrine reuptake inhibitor (SNRI)

Structure and names

Identity: Duloxetine hydrochloride

IUPAC name: (3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride

How Vanguard tests Duloxetine 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, HPLC retention time and a chloride test, assay by HPLC, organic impurities by HPLC with a separate normal-phase HPLC limit for one related compound, plus residue on ignition and loss on drying. Full testing to the USP Duloxetine 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

  • Duloxetine
  • Duloxetine Hydrochloride (CAS 136434-34-9)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

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

Why is duloxetine sold in delayed-release capsules?

Duloxetine breaks down in acid, so it is formulated as enteric-coated pellets. For testing, the pellets are fully extracted so the coating does not hide any of the active.

Does acid degradation show up in the purity result?

It can. Acid breakdown products such as 1-naphthol appear as separate peaks in the HPLC purity method, so a degraded sample shows lower purity and extra impurity peaks.

Is duloxetine a single enantiomer?

Yes, it is the S-enantiomer. A standard reversed-phase HPLC method does not separate it from the R form, so enantiomeric purity is a separate, quoted test.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/60834

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.