Rucaparib Camsylate Suppliers & Bulk Manufacturers

Available Forms: Granules/ Powder

Available Strengths: Purity: ≥ 99% (HPLC, on anhydrous basis)

Reference Brands:

Category: Active Pharmaceutical Ingredient

Rucaparib camsylate API powder, the camphorsulfonate salt of a PARP inhibitor, for formulation of film-coated tablets. For generic developers, contract manufacturers and API distributors needing DMF support.

Product Description:

Rucaparib camsylate is the camphorsulfonate salt of rucaparib, an inhibitor of the poly(ADP-ribose) polymerase enzymes PARP-1, PARP-2 and PARP-3. In tumours with faulty homologous recombination repair, such as those carrying BRCA1 or BRCA2 mutations, blocking PARP leaves DNA damage unrepaired and the cells die. This page covers the active pharmaceutical ingredient, a powder for formulators of film-coated tablets. Finished tablets are labelled by rucaparib base, so the salt factor must be built into the formula.

It is not generally covered by a major pharmacopoeial monograph, so it is bought against the manufacturer's in-house specification, aligned with the reference product's quality expectations. Key tests include identity, assay, related substances by HPLC, residual solvents, water, salt ratio and elemental impurities to ICH Q3D. Like many APIs it can exist in more than one solid form, so the specification should fix the polymorph by XRPD and set particle size limits, since both affect tablet dissolution. Regulators also expect a nitrosamine risk assessment and control of mutagenic impurities under ICH M7.

Sourcing notes. Ask for a DMF or ASMF your finished-product dossier can reference, a GMP certificate covering API manufacture to ICH Q7, and a CoA for every batch with impurity profiles. Request stability data supporting the retest period and storage conditions, usually double polyethylene liners in sealed drums, protected from light and moisture. PARP inhibitors carry reproductive and genotoxic hazards, so both plants need potent-compound containment and an occupational exposure limit from the supplier. Check the patent position in your market. State quantity, solid form, particle size and intended dosage form.