How to Source Mercaptopurine for Pharmaceutical Formulation

Mercaptopurine (Tablets / Oral suspension, 50 mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Purinethol (USA), Purixan (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Mercaptopurine for formulation, R&D, or bulk manufacturing.

Product Overview: Mercaptopurine belongs to a class of medications called purine-antimetabolites. It works by interfering with the DNA and RNA synthesis in rapidly dividing cells, thereby preventing replication and leading to death of abnormal cells. It is used primarily in the treatment of certain blood cancers, such as acute lymphoblastic leukemia.

1. Regulatory Compliance & Documentation

Ensure suppliers provide:

• ✔ Valid DMF (Drug Master File)
• ✔ COA (Certificate of Analysis) for each batch
• ✔ GMP, ISO, or ICH Q7 compliance certificates

2. Purity, Grade & Specification Matching

Mercaptopurine must meet exact grade and purity for your dosage form:

• ✔ USP / EP / JP grade verification
• ✔ Particle size distribution check
• ✔ Residual solvent and heavy metal limits

3. Supplier Reliability & Audit History

• ✔ Positive past audit reports
• ✔ Pharma client references
• ✔ Years of proven API manufacturing experience

4. Commercial Terms: Pricing, MOQ & Flexibility

• ✔ Transparent pricing
• ✔ Pilot batch MOQ flexibility
• ✔ Volume-based discounts

5. Lead Time, Inventory & Logistics

Typical lead time for Mercaptopurine is 4–6 weeks.

• ✔ Emergency dispatch options
• ✔ Regional warehousing
• ✔ Special storage if needed

6. Formulation Support

• ✔ Technical datasheets
• ✔ Sample availability
• ✔ Stability study support

Conclusion

Sourcing Mercaptopurine is more than procurement—it’s a strategic partnership. With its tablets / oral suspension form and 50 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.

Frequently Asked Questions For Sourcing of Mercaptopurine