Nilotinib HCL Monohydrate API
| Name of Product | Nilotinib HCL Monohydrate |
|---|---|
| CAS No | 923288‑90‑8 |
| Therapeutic use:- | Chronic Myelogenous Leukemia |
| Grade | EP/BP |
| Status | Regular |
| Form:- | API Powder |
Product Overview
Nilotinib HCL Monohydrate is an API medication utilized in the manufacturing of anticancer medications. Nilotinib is a member of a category of drugs known as tyrosine kinase inhibitors (TKIs). TKIs inhibit messages from informing cancer cells to grow and develop. When a message is inhibited, cancer cells are less active in growth or grow nothing.
It is used most often to be given in the event of chronic myeloid leukemia (CML), a disease that develops in the bone marrow and the blood. Nilotinib inhibits and blocks the abnormal enzyme, resulting in the formation of these cancerous cells. Nilotinib inhibits and blocks the abnormal enzyme, resulting in the formation of these cancerous cells.
Therapeutic Applications
CML is a condition associated with white blood cells and causes the formation of excessive amounts of immature or faulty cells in the bone marrow. Eventually, these occupy the place of normal blood cells and result in weakness and fatigue, etc. Principal indications are:
- Management of newly diagnosed adult CML with a Philadelphia chromosome.
- Care of patients refractory to Imatinib or intolerant to Imatinib.
By inhibiting the action of the BCR-ABL tyrosine kinase enzyme, Nilotinib inhibits the chain reaction that makes cancer cells survive. It regulates the disease, normalizes blood levels, and stops the threat of the disease advancing. The API is generally utilized in the extended treatment to allow the patients to live healthier and longer.
Specification Parameters
- CAS Number: 923288-90-8
- Molecular Formula: C₂₈H₂₂F₃N₇O·HCl·H₂O
- Molecular Weight: 584.97 g/mol
- Appearance: White to off-white crystalline powder
- Solubility: Soluble in ethanol, alcohol; slightly soluble in water
- Assay (Purity): ≥ 99.0% (HPLC)
- Melting Point: ~ 230 °C (decomposes)
- pH (1% solution): 5.0 – 6.5
Packaging & Storage
Nilotinib HCL Monohydrate is packed in HDPE drums or fibre drums, which are tightly closed and contain two covering polyethylene bags to protect. The usual pack sizes are 1 kg, 5 kg, and 25 kg but special packs can be supplied on request.
It must be kept in a cool, dry, dark place without light and heat. It must be kept at a temperature less than 25 °C with less than 60% humidity. It will decompose as soon as it is exposed to air or if it is overheated.
Product name, batch number, date of manufacture, date of expiry, and special precautions are accurately marked on every container. API is safeguarded from physical damage, heat, and contamination during transport.
Why Choose Us
- Each batch is made with the most recent methods and has more than 99% purity.
- Supplied with uniform quality and performance with our test and control systems.
- Made under rigid Good Manufacturing Practice standards according to international norms.
- With COA, MSDS, stability data, and analysis reports for filing with the regulatory authorities.