Lorlatinib is a third-generation macrocyclic tyrosine kinase inhibitor (TKI) that selectively targets anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1). It is used as an active pharmaceutical ingredient in targeted oncology formulations and pharmaceutical development.
Lorlatinib has the CAS Number 1454846-35-5, molecular formula C21H19FN6O2 and molecular weight 406.41 g/mol. It is a small-molecule kinase inhibitor developed for the treatment of ALK-positive non-small cell lung cancer (NSCLC).
Lorlatinib is a macrocyclic ALK and ROS1 tyrosine kinase inhibitor designed to block kinase activity. It can inhibit several ALK alterations associated with resistance to earlier-generation ALK inhibitors.
Its macrocyclic structure contributes to activity against a broad range of ALK mutations. Lorlatinib is supplied as a pharmaceutical active ingredient for formulation development and qualified manufacturing applications.
Lorlatinib inhibits ALK and ROS1 tyrosine kinase activity. By blocking abnormal kinase signaling, it interferes with pathways involved in tumor-cell proliferation and survival.
Its macrocyclic structure enables activity against multiple ALK resistance mutations and supports its use as a targeted oncology therapy.
Lorlatinib can be characterized using validated chromatographic and spectroscopic analytical methods. HPLC may be used for assay and related-substance determination, while suitable spectroscopic and chromatographic techniques may be used for identity confirmation.
Quality control may include identity, assay, related substances, water content, residual solvents, elemental impurities and other applicable parameters according to the approved product specification.
Lorlatinib should be stored in a tightly closed container under controlled pharmaceutical storage conditions. The material should be protected from excessive heat, moisture, direct light and contamination. Specific storage requirements should follow the applicable manufacturer specification and Certificate of Analysis.
Lorlatinib API may be supplied for pharmaceutical manufacturing, formulation development, analytical testing and qualified oncology research applications. Product specifications, Certificate of Analysis, packaging configuration and regulatory documentation should be confirmed according to the intended application.
Swapproop Drugs and Pharmaceuticals supports the sourcing and supply of Lorlatinib API for qualified pharmaceutical manufacturing, formulation development and research requirements.
Customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details for Lorlatinib API.
| 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 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |