How to Source Prolonged-release Potassium Chloride Generics for Pharmaceutical Formulation

Prolonged-release Potassium Chloride Generics (Tablet, 8 mEq (600 mg), 10 mEq (750 mg), 15mEq (1,125 mg), 20mEq (1,500 mg)) is classified under Nephrology. It is therapeutically aligned with reference brands such as Klor-Con®, K-Dur®, K-Tab®, Micro-K® (US), KCl Retard®, Kaleorid®, Kalium-Retard®, Slow-K® (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Prolonged-release Potassium Chloride Generics for formulation, R&D, or bulk manufacturing.

Product Overview: Prolonged-release Potassium Chloride is an oral electrolyte supplement used to treat and prevent hypokalemia, especially in CKD and patients on diuretics, offering controlled potassium release for stable serum levels.

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

Prolonged-release Potassium Chloride Generics 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 Prolonged-release Potassium Chloride Generics 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 Prolonged-release Potassium Chloride Generics is more than procurement—it’s a strategic partnership. With its tablet form and 8 mEq (600 mg), 10 mEq (750 mg), 15mEq (1,125 mg), 20mEq (1,500 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 Prolonged-release Potassium Chloride Generics