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Mixture of Paroxetine Hydrochloride With Paroxetine USP Related Compound E

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Description

Chemical Name: (3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine compound with 4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine (1:1) hydrochloride

Shipping Temperature:
Ambient

HSN Code:
38229010

Country of Origin: India

Smiles: FC1=CC=C([C@@H]2CCNC[C@H]2COC3=CC=C(OCO4)C4=C3)C=C1.FC5=CC=C(C6=CCN(C)CC6)C=C5.Cl

Additional Information

Mixture of Paroxetine Hydrochloride With Paroxetine USP Related Compound E is chemically (3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine compound with 4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine (1:1) hydrochloride.
Mixture of Paroxetine Hydrochloride With Paroxetine USP Related Compound E is supplied with detailed characterization data compliant with regulatory guideline. Mixture of Paroxetine Hydrochloride With Paroxetine USP Related Compound E can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Paroxetine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API)