Trametinib is a synthetic small-molecule mitogen-activated protein kinase kinase (MEK1/MEK2) inhibitor used as an antineoplastic agent. The active pharmaceutical ingredient is commonly supplied pharmaceutically as Trametinib Dimethyl Sulfoxide, a 1:1 DMSO addition compound. Trametinib itself has CAS 871700-17-3, while the pharmaceutical Trametinib Dimethyl Sulfoxide has CAS 1187431-43-1.
The FDA describes Trametinib Dimethyl Sulfoxide as a kinase inhibitor. The pharmaceutical form has molecular formula C₂₈H₂₉FIN₅O₅S and molecular mass 693.53 g/mol. The FDA label describes it as a white to almost white powder and practically insoluble in aqueous media across pH 2–8.
Trametinib inhibits MEK1 and MEK2 activation and kinase activity, thereby suppressing signaling through the RAS/RAF/MEK/ERK pathway.
Trametinib is marketed as MEKINIST. It is used in several BRAF- or MEK-pathway-driven cancers, including BRAF V600E/V600K-mutated melanoma and, in combination with dabrafenib, certain other BRAF V600 mutation-positive malignancies. FDA records also document its approval in combination with dabrafenib for pediatric patients with BRAF V600E-mutated low-grade glioma.
For API identification, it is important to distinguish Trametinib (free active moiety) from Trametinib Dimethyl Sulfoxide, because the latter is the pharmaceutical substance used in MEKINIST. FDA labeling states that 0.5 mg of non-solvated trametinib corresponds to 0.5635 mg Trametinib Dimethyl Sulfoxide, while 2 mg corresponds to 2.254 mg of the DMSO addition compound.
Trametinib is a targeted oncology API that inhibits MEK1 and MEK2, important downstream components of the MAPK signaling pathway. By inhibiting MEK signaling, trametinib can reduce proliferation of tumors driven by aberrant MAPK pathway activation.
FDA has approved MEKINIST for indications including unresectable or metastatic melanoma with BRAF V600E or V600K mutations and, in combination with dabrafenib, pediatric BRAF V600E-mutated low-grade glioma requiring systemic therapy.
Swapnroop Drugs & Pharmaceuticals provides pharmaceutical API sourcing and supply support for Trametinib / Trametinib Dimethyl Sulfoxide for qualified pharmaceutical manufacturing, formulation development and bulk API requirements.
As a Trametinib API manufacturer and supplier in India, Swapnroop focuses on specification-based sourcing, product identity, documentation, traceability, appropriate packaging and pharmaceutical quality requirements.
Customers requiring Trametinib Dimethyl Sulfoxide API can request product specifications, Certificate of Analysis, technical documentation and bulk supply information according to their requirements.
Trametinib Dimethyl Sulfoxide should be handled and packaged according to the applicable drug-substance specification and validated stability conditions.
The finished MEKINIST product has specific storage requirements that should not automatically be interpreted as the bulk API storage specification. Appropriate protection from moisture, contamination and unsuitable environmental conditions should be maintained.
Documentation may include:
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies seeking Trametinib API manufacturer and supplier services in India.
The supply approach emphasizes:
For Trametinib Dimethyl Sulfoxide API requirements, customers can contact Swapnroop for availability, specifications, documentation and commercial supply information.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |
| Water Content | NMT 1.0% |