How to Source Quinidine gluconate for Pharmaceutical Formulation

Quinidine gluconate (Tablet / Oral Solution, 200 mg, 324 mg, 300 mg/5 mL) is classified under Heart Disorder. It is therapeutically aligned with reference brands such as Generic formulations marketed under different names. This guide highlights key sourcing factors buyers should consider when procuring high-quality Quinidine gluconate for formulation, R&D, or bulk manufacturing.

Product Overview: Quinidine is a naturally derived alkaloid and the D-isomer of quinine, originally isolated from the...

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

Quinidine gluconate 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 Quinidine gluconate 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 Quinidine gluconate is more than procurement—it’s a strategic partnership. With its tablet / oral solution form and 200 mg, 324 mg, 300 mg/5 mL 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 Quinidine gluconate