PHARMA & HEALTCARE
Zinc oxide is widely used in pharmaceutical formulations, dermatological preparations and regulated healthcare applications where purity, consistency and regulatory compliance are critical. Pharmaceutical-grade zinc oxide requires strict control of the trace metal profile, defined particle characteristics and full batch traceability. Production is typically performed under GMP-controlled conditions, supported by appropriate regulatory documentation depending on the target market. Depending on the regulatory pathway, documentation may include EP/USP pharmacopoeial compliance, DMF/ASMF documentation or CEP registration.
Key Requirements
Regulatory Compliance & Documentation
Pharmaceutical applications require full regulatory support, including DMF/ASMF documentation and, where applicable, CEP certification. Comprehensive documentation and transparent change control procedures are essential to support product registration and lifecycle management.
GMP Manufacturing & Traceability
Production must be performed under pharmaceutical GMP conditions with validated processes, documented quality systems and complete batch traceability. This ensures patient safety, regulatory acceptance and long-term supply reliability.
EP / USP Compliance
Material must comply with applicable pharmacopoeia standards (EP, USP or other relevant monographs). Consistent conformity with pharmacopeial specifications safeguards product quality and facilitates global dossier approvals.
Controlled Trace Metal Profile
Very low and tightly controlled trace metal levels are critical in pharmaceutical applications. A defined impurity profile ensures safety, regulatory compliance and suitability for sensitive topical and oral formulations.
Typical Properties
Pharmaceutical-grade zinc oxide is characterized by a highly controlled trace metal profile, defined particle characteristics and full batch traceability. Production under GMP-controlled conditions ensures consistent product quality, supported by regulatory documentation when required (DMF/ASMF/CEP track).
- Regulatory Sensitivity
- Highly regulated
