(R)-3-(Methylamino)-1-(thiophen-2-YL)propan-1-OL
- CAS
- 116539-57-2
- Formula
- C8H13NOS
- MW
- 171.26 g/mol
ZX-020265
Impurity reference standards
Duloxetine impurity standards
For Duloxetine, the Zemixal catalogue holds 42 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 10 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard and 6 metabolites or hydroxylated analogues.
42reference materials
10pharmacopoeial
2nitrosamines
1isotope labelled
Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial10EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites6Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Duloxetine reference materials
1–42 of 42 standards
(S)-3-(Dimethylamino)-1-(thiophen-3-yl)propan-1-ol
- CAS
- 1384080-56-1
- Formula
- C9H15NOS
- MW
- 185.29 g/mol
ZX-029126
1-Beta-Hydroxy-1-(2-thienyl)-3-methylaminopropan
- CAS
- 116539-56-1
- Formula
- C8H13NOS
- MW
- 171.26 g/mol
ZX-024408
3-(Dimethylamino)-1-(thiophen-2-yl)propan-1-one Hydrochloride
- CAS
- 5424-47-5
- Formula
- C9H14ClNOS
- MW
- 219.73 g/mol
ZX-033355
3-[methyl(nitroso)amino]-1-(thiophen-2- yl)propan-1-ol
- CAS
- 2418708-78-6
- Formula
- C8H12N2O2S
- MW
- 200.26 g/mol
ZX-006091
3-Hydroxy-N-methyl-3-(thiophen-2-yl)propanamide
- CAS
- 603996-87-8
- Formula
- C8H11NO2S
- MW
- 185.25 g/mol
ZX-029122
RS-N,N- Dimethyl-3-(1-Naphthalenyloxy)-3-(2-thienyl)-1-propanamine oxalate
- CAS
- 116817-12-0
- Formula
- C19H21NOS
- MW
- 311.4 g/mol
ZX-029124
S-(+)-N,N-Dimethyl-3-(1-naphthalenyloxy)-3-(2-thienyl)-1-propanamine oxalate
- CAS
- 132335-47-8
- Formula
- C21H23NO5S
- MW
- 401.5 g/mol
ZX-024405
S(-)-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)-1-propanamine
- CAS
- 132335-44-5
- Formula
- C9H15NOS
- MW
- 185.29 g/mol
ZX-024407
Questions
Duloxetine impurities, answered
What Duloxetine reference materials are available?
The catalogue currently lists 42 compounds for Duloxetine, including 10 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard and 6 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Duloxetine impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Duloxetine impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
Do you supply Duloxetine nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Duloxetine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Duloxetine standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.