Fluzoparib API Manufacturer in India

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Fluzoparib API Manufacturer in India

Fluzoparib API is a small-molecule poly(ADP-ribose) polymerase (PARP) inhibitor, also known as Fuzuloparib, SHR-3162, and HS10160. It is identified by CAS Number 1358715-18-0, with the molecular formula C₂₂H₁₆F₄N₆O₂ and molecular weight 472.40 g/mol.

Fluzoparib is chemically identified as 4-[[4-fluoro-3-[2-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[1,5-a]pyrazine-7-carbonyl]phenyl]methyl]-2H-phthalazin-1-one. It is an achiral compound with no defined stereocenters.

Fluzoparib Chemical Properties

Fluzoparib has a molecular formula of C₂₂H₁₆F₄N₆O₂, molecular weight 472.40 g/mol, and CAS Number 1358715-18-0. FDA's substance record confirms that the compound is achiral and has no optical activity.

Commercial research-grade material is supplied as a solid/powder. Cayman Chemical reports ≥98% purity, while Selleck reports a tested batch purity of 99.88%.

Fluzoparib API Quality

Available commercial specifications support HPLC purity of ≥98.0%. Since Fluzoparib is an investigational compound rather than a conventional established pharmacopoeial API, a current USP/IP/BP/Ph. Eur. monograph with complete release specifications is not available in the sources reviewed.

Fluzoparib Applications

Fluzoparib is an orally active PARP inhibitor that has been investigated for its potential antineoplastic activity, including research involving BRCA1/2-mutated and homologous-recombination-deficient cancers.

Fluzoparib API Supply

Fluzoparib may be supplied for pharmaceutical research, analytical development and drug-development applications subject to applicable regulatory requirements. Commercial reference materials are generally designated for research use rather than established human pharmaceutical use.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
Individual Impurity NMT 1.0%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
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