Pharma GMP Grade EP/USP (Non-API Track)
Pharma grade zinc oxide EP/USP (Non-API Track) is developed for pharmaceutical and healthcare applications requiring high purity and compliance with pharmacopoeia standards.
Produced under GMP conditions, this zinc oxide is suitable for non-API pharmaceutical use, offering consistent quality, controlled impurities and full traceability. It is designed for applications where regulatory compliance and product reliability are essential.
Positioning
Designed for pharmaceutical and healthcare applications requiring high purity zinc oxide compliant with EP and USP standards, without the need for API or CEP regulatory pathways.
Technical Specifications
- Purity Range
- 99.0 – 100.5 % (Ph. Eur. / USP)
- GMP
- Manufactured under GMP conditions in accordance with ICH Q7 guidelines
- API suitability
- Suitable for pharmaceutical API development
- Suitable
- Suitable to support DMF / ASMF regulatory pathways
- Regulatory pathway
- Suitable for DMF / ASMF based API registration pathways
- Pharmacopoeial compliance
- European Pharmacopoeia (Ph. Eur.) / United States Pharmacopeia (USP)
Typical Use
Used in pharmaceutical formulations, dermatological products and healthcare applications where pharmacopoeia compliance and consistent quality are required.
