Pharma GMP Grade EP/USP (CEP Track)

GMP EP/USP zinc oxide designed for API applications

High purity zinc oxide produced under GMP conditions, compliant with Ph. Eur. / USP monographs and aligned with ICH Q7, supporting pharmaceutical applications through an open DMF approach.

Positioning

Designed for pharmaceutical applications requiring GMP-controlled production and full regulatory transparency.
Supports API registration via an open DMF structure, enabling direct customer access and faster dossier integration.

Technical Specifications

Purity Range

99.0 – 100.5 % (Ph. Eur. / USP)

GMP

Pharma GMP zinc oxide (EP / USP compliant)

API suitability

Suitable for API development

Regulatory framework

European Pharmacopoeia alignment

Pharmaceutical-grade

Pharmaceutical-grade impurity control

Regulatory

CEP pathway compatibility (EDQM)

Typical Use

Used in pharmaceutical formulations and active pharmaceutical ingredient (API) applications requiring high purity, traceability and compliance with pharmacopoeia standards.