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Pharma GMP Grade EP/USP (API Track)
This grade is manufactured under full GMP conditions and intended for use as an Active Pharmaceutical Ingredient (API). It follows regulatory pathways suitable for global API registration.
Positioning
Designed for pharmaceutical manufacturers requiring high-purity zinc oxide suitable for Active Pharmaceutical Ingredient (API) development and manufacturing, with controlled impurity profiles supporting regulatory submission pathways such as DMF or ASMF.
Consistent batch-to-batch quality supporting reliable pharmaceutical manufacturing.
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
Pharmaceutical formulations and other regulated healthcare applications requiring controlled impurity profiles and pharmacopoeial compliance.
