Pralatrexate Disodium is a sodium salt form of pralatrexate, a synthetic antifolate and antineoplastic active pharmaceutical ingredient used in oncology. Pralatrexate is a folate analogue designed to interfere with folate-dependent cellular metabolism and inhibit enzymes involved in nucleotide synthesis. The parent pralatrexate has the molecular formula C23H23N7O5 and molecular weight 477.48 g/mol.
Pralatrexate disodium is specifically identified in patent literature as the disodium salt of pralatrexate, also designated Na-PLT or compound 10a. It is formed by converting the two carboxylic acid groups of pralatrexate into their sodium salt form. Based on the disodium salt stoichiometry, the anhydrous molecular formula is C23H21N7Na2O5 and the calculated molecular weight is approximately 521.44 g/mol. The exact solid-state form and hydration state should be stated on the applicable specification or Certificate of Analysis because crystalline pralatrexate disodium has been reported with significant water content.
Pralatrexate is a 10-deazaaminopterin analogue and belongs to the antifolate class of antineoplastic compounds. It acts principally through inhibition of dihydrofolate reductase (DHFR) and interferes with folate-dependent biochemical pathways required for synthesis of thymidylate, purine nucleotides and other cellular components.
The parent pralatrexate substance is a 1:1 racemic mixture of S- and R-diastereomers at the C10 position. This stereochemical characteristic remains important when characterizing the corresponding disodium salt.
Patent literature describes both crystalline and amorphous Pralatrexate Disodium. A disclosed crystalline preparation produced a pale yellow solid with a reported purity of 99.6% and a water content of 10.3% w/w. These are process-example results and should not be treated as universal commercial API release specifications.
Pralatrexate is an established oncology API associated with the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). The approved pharmaceutical product FOLOTYN contains pralatrexate and is administered intravenously.
Pralatrexate disodium is particularly relevant to pharmaceutical development and manufacturing where the sodium-salt form is required as an intermediate or active pharmaceutical substance. Patent disclosures specifically describe pharmaceutical compositions containing pralatrexate salts, including the disodium form.
Pralatrexate Disodium requires salt-specific characterization because the sodium salt differs from the parent free-acid API in molecular composition, ionic state, solid-state properties and water content.
Important quality attributes can include identity, assay, related substances, sodium content, water content, residual solvents, solid-state form and chromatographic purity. Where the crystalline form is controlled, powder X-ray diffraction (XRPD) can be used to confirm the intended polymorphic form. Patent literature reports characteristic XRPD peaks for crystalline Pralatrexate Disodium at approximately 3.5°, 6.9° and 13.8° 2θ, with an experimental tolerance of ±0.2°.
A separate patent example reports a crystalline Pralatrexate Disodium preparation with 99.6% purity and 10.3% water content. Because these figures originate from a specific manufacturing example rather than an official pharmacopoeial monograph, they should be treated as reference/process data rather than universal API specifications.
A Pralatrexate Disodium API manufacturer in India should maintain tight control over salt formation, crystallization, purification and solid-state characteristics. The manufacturing process should distinguish the disodium salt from free pralatrexate and verify the final sodium-salt form using appropriate analytical techniques.
Process controls can include reaction monitoring by HPLC, controlled pH during salt formation, controlled temperature during crystallization and appropriate drying conditions. Patent examples demonstrate conversion of pralatrexate or its ester intermediates into sodium-salt forms using sodium hydroxide under controlled processing conditions.
Because the API is associated with oncology applications, appropriate containment, occupational safety and hazardous-drug handling procedures should also be incorporated into the manufacturing and quality-control program.
Pralatrexate Disodium should be packaged in suitable pharmaceutical-grade containers that protect the material from moisture, contamination and environmental exposure. This is particularly important because disclosed crystalline material demonstrated measurable water content.
The exact storage condition should be based on validated API stability data and the applicable registered specification. A finished Pralatrexate injection storage condition should not automatically be transferred to the bulk disodium API.
Typical documentation for Pralatrexate Disodium API can include:
Pralatrexate Disodium is a specialized salt form of an established antifolate oncology API. Its defined sodium-salt structure, reported crystalline and amorphous forms, and documented pharmaceutical relevance make accurate identity and solid-state characterization important for API manufacturing.
For pharmaceutical organizations looking for Pralatrexate Disodium API Manufacturer in India, key quality considerations include salt identity, assay, related substances, sodium content, water content, residual solvents, solid-state form and comprehensive analytical documentation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | 10.3% |
| Melting Point | 10.3% w/w |