Duloxetine Hydrochloride
SIAL/PHR1865 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: (S)-Duloxetine hydrochloride; (γS)-N-Methyl-γ-(1-naphthalenyloxy)-2-thiophenepropanamine hydrochloride; (+)-(S)-N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride; (+)
CAS Number: 136434-34-9
Empirical Formula (Hill Notation): C18H19NOS · HCl
Molecular Weight: 333.88
MDL Number: MFCD06407958
Linear Formula: C18H19NOS · HCl
Product Type: Chemical
| agency | traceable to Ph. Eur. Y0001453 |
| traceable to USP 1229817 | |
| API family | duloxetine |
| application(s) | pharmaceutical |
| CofA | current certificate can be downloaded |
| form | powder |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C18H19NOS.ClH/c1-19-12 |
| InChI key | BFFSMCNJSOPUAY-LMOVPXPDSA |
| packaging | pkg of 500 mg |
| Quality Level | 300 ![]() |
| SMILES string | Cl.CNCC[C@H](Oc1cccc2cccc |
| storage temp. | 2-30°C |
| Analysis Note: | These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available. |
| Application: | This pharmaceutical secondary standard can also be used as follows: • Development of two voltammetry methods using carbon paste electrode, for the trace analysis of duloxetine hydrochloride in pharmaceutical dosage forms and human serum samples • Separation and estimation of curcumin and duloxetine hydrochloride by reversed-phase high-performance liquid chromatography (RP-HPLC) from bulk and pharmaceutical formulations • Determination of duloxetine in pure form by a UV-Vis spectrophotometric method, in accordance with the ICH Q2R1 guidelines • Multi-analysis of antidepressant drugs― vilazodone hydrochloride, agomelatine, and duloxetine hydrochloride along with vitamin B12 in their bulk, pharmaceutical formulations, and human urine samples using HPLC |
| Biochem/physiol Actions: | Duloxetine hydrochloride is a dual serotonin/norepinephrine reuptake inhibitor (SNRI), widely used clinically as an antidepressant and anxiolytic. |
| Biochem/physiol Actions: | Duloxetine hydrochloride is a dual serotonin/norepinephrine reuptake inhibitor (SNRI); antidepressant; anxiolytic. |
| General description: | This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis. Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Duloxetine Hydrochloride, a thiophene derivative, belongs to the class of selective serotonin-norepinephrine reuptake inhibitors (SNRI), used for its anti-depressant properties. |
| Other Notes: | Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial . |
| Other Notes: | To see an example of a Certificate of Analysis for this material enter LRAC1689 in the Documents slot below. This is an example certificate only and may not be the lot that you receive. |
| Symbol | GHS07 |
| Signal word | Warning |
| Hazard statements | H302 |
| Precautionary statements | P301 + P312 + P330 |
| RIDADR | NONH for all modes of transport |
| WGK Germany | WGK 3 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | 2-30°C |
| UNSPSC | 41116107 |


