Pharmaceutical Purified Water Demineralization Resin
Mixed or separate bed ion exchange resin system for pharmaceutical purified water meeting USP <1231> and EP 2.2.3 conductivity and TOC requirements with full cGMP documentation.
Technical Specifications
| TOC | < 500 ppb |
| standard | USP <1231> and EP 2.2.3 compliant |
| packaging | 25 L sealed bag |
| appearance | Mixed H/OH-form spherical beads |
| conductivity | < 1.3 μS/cm (USP Purified Water) |
| documentation | cGMP batch records and CoA available |
Applications
- Pharmaceutical purified water (USP/EP) production
- Water for injection (WFI) pre-treatment
- API manufacturing process water
- Sterile product rinsing water
- Biopharmaceutical buffer preparation water
Key Features
- Meets USP <1231> and EP 2.2.3 Purified Water specifications
- Full cGMP documentation — batch records, CoA, extractables data
- Low TOC leachables — suitable for sensitive API processes
- Available as mixed bed or separate cation/anion bed system
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