Description

Oxaliplatin

Oxaliplatin is a third-generation platinum-based antineoplastic agent used in the treatment of colorectal and other gastrointestinal cancers. It functions by forming DNA cross-links that inhibit DNA replication and transcription, leading to apoptosis in rapidly dividing tumor cells. With a distinct activity profile from cisplatin and carboplatin, Oxaliplatin is a critical component in modern chemotherapeutic regimens, especially in combination protocols such as FOLFOX.

• Platinum-based cytotoxic agent with activity against colorectal and GI cancers
• Suitable for sterile injectable formulation (IV infusion)
• Exhibits less nephrotoxicity and ototoxicity than earlier platinum analogs
• Commonly used in combination with 5-fluorouracil (5-FU) and leucovorin
• Manufactured under Good Manufacturing Practice (GMP) certified conditions
• Supplied with full regulatory documentation including Certificate of Analysis (CoA), Drug Master File (DMF), and supporting technical data

Chemically known as (1R,2R)-cyclohexane-1,2-diamineplatinum(II), Oxaliplatin appears as a white to off-white crystalline powder and is highly sensitive to light and moisture. It is sparingly soluble in water and typically supplied as a lyophilized powder for reconstitution in 5% dextrose.

In pharmaceutical applications, Oxaliplatin is used in:

• Colorectal cancer (CRC) treatment, both adjuvant and metastatic settings
• Combination protocols (e.g., FOLFOX, XELOX) in gastrointestinal malignancies
• Advanced gastric and pancreatic cancers as part of off-label or investigational regimens
• Pediatric oncology and hematologic malignancies in select treatment centers
• Compounded IV infusions in hospital and oncology clinics

Unlike cisplatin, Oxaliplatin does not require extensive hydration protocols and is less nephrotoxic. However, it is associated with dose-limiting peripheral neuropathy and should be dosed cautiously in patients with preexisting neurologic conditions.

CarboMer supplies Oxaliplatin with validated controls on platinum content, assay, residual solvents, and heavy metals. Each batch conforms to ICH and pharmacopeial standards for use in sterile injectable dosage forms.

Material is packaged in tamper-evident, light-protective containers. Cold-chain handling is supported upon request. Available in GMP-intermediate, sterile, or lyophilized formats depending on manufacturing stage. Minimum order quantities (MOQ), lead times, and documentation

including CoA, SDS, and DMF are available upon request.

Each batch is tested for identity (IR, UV, HPLC), assay (anhydrous basis), residual solvents, platinum content, heavy metals, and microbiological purity (for sterile grades). Full traceability documentation and analytical validation reports are available.

As with all CarboMer cytotoxic APIs, Oxaliplatin is supported by comprehensive regulatory consulting, formulation development guidance, and secure supply chain logistics to help bring high-impact oncology products safely to market.