PHR1804

Paroxetine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Paroxetine hydrochloride hemihydrate, (3S-trans)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride hemihydrate
• Empirical Formula (Hill Notation): C₁₉H₂₀FNO₃ · HCl · .5 H₂O
• CAS Number: 110429-35-1
• Molecular Weight: 374.83
• MDL number: MFCD03658863
• PubChem Substance ID: 329823624

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 1024; traceable to Ph. Eur. Y0000281; traceable to USP 1500218
• API family: paroxetine
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: O.Cl[H].Fc1ccc(cc1)[C@@H]2CCNC[C@H]2COc3ccc4OCOc4c3
• InChI: 1S/C19H20FNO3.ClH.H2O/c20-15-3-1-13(2-4-15)17-7-8-21-10-14(17)11-22-16-5-6-18-19(9-16)24-12-23-18;;/h1-6,9,14,17,21H,7-8,10-12H2;1H;1H2/t14-,17-;;/m0../s1
• InChI key: QRQSGFFISBKLMZ-YHOFXEKLSA-N
• Gene Information: human ... SLC6A4(6532)

Description

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.

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

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

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.

Safety Information

• Pictograms: GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H302 - H317 - H319 - H335 - H410
• Precautionary Statements: P261 - P273 - P280 - P301 + P312 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Irrit. 2 - Skin Sens. 1 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable