Nelarabine is a synthetic purine nucleoside analogue and antineoplastic pharmaceutical API used in oncology. It is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G) and is converted intracellularly to active ara-G nucleotides, ultimately interfering with DNA synthesis.
Nelarabine is primarily associated with pharmaceutical formulations for T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). Its development code and commonly reported synonym include 506U78 / GW506U78.
Nelarabine is a well-characterized antineoplastic purine nucleoside analogue API relevant to oncology formulation development, pharmaceutical research, analytical testing and manufacturing applications.
Important API quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, optical purity and other applicable pharmaceutical quality parameters.
CAS Number: 121032-29-9
Molecular Formula: C11H15N5O5
Molecular Weight: 297.27 g/mol
Chemical Name: 9-β-D-Arabinofuranosyl-6-methoxy-9H-purin-2-amine
Development Code: 506U78 / GW506U78
Drug Class: Purine Nucleoside Analogue
Therapeutic Class: Antineoplastic / Antimetabolite
Therapeutic Area: Oncology / Hematology
Molecule Type: Synthetic Small Molecule
The CAS number, molecular formula and molecular weight are consistent across PubChem and chemical-reference sources.
Nelarabine functions as a prodrug of ara-G. Following conversion to active nucleotide metabolites, its pharmacological activity interferes with DNA synthesis.
Its mechanism includes:
Nelarabine is particularly relevant to T-cell malignancies, including T-ALL and T-LBL.
Nelarabine API is relevant to:
Nelarabine is used as an antineoplastic agent in the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, particularly in specified relapsed or refractory disease settings depending on the applicable regulatory labeling.
Its activity is associated with the intracellular formation of ara-GTP and subsequent disruption of DNA synthesis.
Nelarabine belongs to the purine nucleoside analogue class. Structurally, it is a modified guanine nucleoside in which a methoxy group is present on the purine ring.
Its nucleoside structure enables intracellular conversion to active metabolites that interfere with DNA replication, making it relevant to antineoplastic drug development and T-cell malignancy research.
Nelarabine is generally described as a white to off-white powder or solid. Chemical-reference data report a melting range around 209–217°C, while different research-product sources can report differing physical-property measurements.
Nelarabine is reported to have limited aqueous solubility under ordinary conditions, with some sources reporting approximately 5 mg/mL in water when warmed.
A controlled Nelarabine API manufacturing process may involve:
Typical Nelarabine API testing may include:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 0.5% |