Paroxetine hydrochloride
SIAL/PHR1804 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: Paroxetine hydrochloride hemihydrate; (3S-
CAS Number: 110429-35-1
Empirical Formula (Hill Notation): C19H20FNO3 · HCl · .5 H2O
Molecular Weight: 374.83
MDL Number: MFCD03658863
Linear Formula: C19H20FNO3 · HCl · .5 H2O
Product Type: Chemical
| agency | traceable to BP 1024 |
| traceable to Ph. Eur. Y0000281 | |
| traceable to USP 1500218 | |
| API family | paroxetine |
| application(s) | pharmaceutical (small molecule) |
| CofA | current certificate can be downloaded |
| format | neat |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C19H20FNO3.ClH.H2O/c20 |
| InChI key | QRQSGFFISBKLMZ-YHOFXEKLSA |
| packaging | pkg of 500 mg |
| Quality Level | 300  |
| SMILES string | O.Cl[H].Fc1ccc(cc1)[C@@H] |
| storage temp. | 2-8°C |
| technique(s) | gas chromatography (GC): suitable |
| HPLC: suitable |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available. |
| Application: | This pharmaceutical secondary standard can also be used as follows: • Development of a reversed phase high-performance liquid chromatographic (RP-HPLC) method for the determination of paroxetine and clonazepam in pharmaceutical tablet forms • High-performance thin-layer chromatographic (HPTLC) determination of paroxetine and clonazepam in pharmaceutical formulations following International Conference on Harmonization (ICH) guidelines • Chiral and achiral impurity profiling of paroxetine hydrochloride using supercritical fluid chromatography (SFC) and a chiral stationary phase • Determination of seven phosphodiesterase-5 inhibitors and serotonin reuptake inhibitors by HPLC combined with diode array detection (DAD) from tablet dosage forms • Separation and estimation of paroxetine from its enantiomeric and diastereomeric impurities by an HPLC method using an amylose-based chiral stationary phase |
| Biochem/physiol Actions: | Paroxetine hydrochloride hemihydrate is one of the most potent and selective of the selective serotonin reuptake inhibitors (SSRI); antidepressant |
| Footnote: | To see an example of a Certificate of Analysis for this material enter LRAB7850 in the Documents slot below. This is an example certificate only and may not be the lot that you receive. |
| 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. Paroxetine hydrochloride, a phenylpiperidine derivative, is a selective serotonin reuptake inhibitor (SSRI) used for its anti-depressant properties. It is used to treat major depression, post-traumatic stress disorder (PTSD), panic disorder, and obsessive-compulsive disorder (OCD) among others. |
| Symbol |   GHS07,GHS09 |
| Signal word | Warning |
| Hazard statements | H302 - H411 |
| Precautionary statements | P273 - P301 + P312 + P330 |
| RIDADR | UN 3077 9 / PGIII |
| WGK Germany | WGK 3 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | 2-8°C |
| UNSPSC | 41116107 |