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Pharma GMP Grade EP/USP (CEP Track)
Developed as a high-purity API grade, this zinc oxide is manufactured under GMP conditions and designed to support the CEP (Certificate of Suitability) pathway with the European Pharmacopoeia.
Positioning
For pharmaceutical companies seeking high-purity zinc oxide suitable for Active Pharmaceutical Ingredient (API) development and CEP-based regulatory pathways, facilitating simplified regulatory submissions in Europe.
Technical Specifications
- Purity Range
- 99.0 – 100.5 % (Ph. Eur. / USP)
- GMP
- GMP manufactured
- API suitability
- Suitable for API development under GMP conditions
- Regulatory pathway
- Suitable for CEP (EDQM) registration pathway
- Regulatory framework
- European Pharmacopoeia alignment
- Pharmaceutical-grade
- Pharmaceutical-grade impurity control
Typical Use
Used in pharmaceutical formulations and other regulated healthcare applications where high purity, traceability and regulatory compliance are critical.
