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.
Duloxetine hydrochloride: 2D structure drawn from the PubChem record (CID 60834).
136434-34-9
C18H19NOS · HCl
333.88 g/mol
Serotonin and norepinephrine reuptake inhibitor (SNRI)
Identity: Duloxetine hydrochloride
IUPAC name: (3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;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.
Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.
| 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.
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.
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.
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.
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.
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.
https://pubchem.ncbi.nlm.nih.gov/compound/60834
Identity facts from the USP monograph header for this compound.
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