How to Source Triprolidine HCl + Pseudoephedrine HCl for Pharmaceutical Formulation

Triprolidine HCl + Pseudoephedrine HCl (Tablet & Oral solution, Tab: 2.5 mg/60 mg; Oral Solution: 0.5 mg/mL, 0.625 mg/mL, 0.938 mg/mL, and 1.25 mg/mL) is classified under Respiratory Disorder. It is therapeutically aligned with reference brands such as Histex®, Vanahist PD®, M-Hist PD®, PediaClear®, Aprodine®, Zymine®, Allerfrim®, ENDAL®. This guide highlights key sourcing factors buyers should consider when procuring high-quality Triprolidine HCl + Pseudoephedrine HCl for formulation, R&D, or bulk manufacturing.

Product Overview: Triprolidine is an effective first-generation antihistamine used for allergies and cold symptoms. Available in 2.5 mg tablets and syrups, it’s often combined with pseudoephedrine. Sold under brands like Aprodine®, Zymine®, and Actifed®, it's popular in the US and EU for B2B, PCD, and export markets.

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

Triprolidine HCl + Pseudoephedrine HCl 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 Triprolidine HCl + Pseudoephedrine HCl 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 Triprolidine HCl + Pseudoephedrine HCl is more than procurement—it’s a strategic partnership. With its tablet & oral solution form and Tab: 2.5 mg/60 mg; Oral Solution: 0.5 mg/mL, 0.625 mg/mL, 0.938 mg/mL, and 1.25 mg/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 Triprolidine HCl + Pseudoephedrine HCl