How to Source Diphenhydramine Hydrochloride for Pharmaceutical Formulation

Diphenhydramine Hydrochloride (Injection, 50 mg/mL in 1 mL or 2 mL vials) is classified under Allergy Medication. It is therapeutically aligned with reference brands such as Benadryl®. This guide highlights key sourcing factors buyers should consider when procuring high-quality Diphenhydramine Hydrochloride for formulation, R&D, or bulk manufacturing.

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

Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride is more than procurement—it’s a strategic partnership. With its injection form and 50 mg/mL in 1 mL or 2 mL vials 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 Diphenhydramine Hydrochloride