Our USP Purified Water is available in sterile and non-sterile formats, and complies with the USP monograph for purified water.
- Pharmaceutical formulations that are not intended to be sterile and apyrogenic
- Oral and topical products
- Granulation processes for tablets and capsules
- IVD Manufacturing
- Medical Device Manufacturing
- Process Equipment Cleaning & Rinsing
- Manufactured under cGMP and ISO 13485 guidelines in a FDA registered facility
- Nitrosamine Impurity Free
ILS Purified Water United States Pharmacopeia (USP) grade can be used as an excipient in the production of non-parenteral preparations such as cleaning of certain equipment and non-parenteral product-contact components. Available in sterile and non-sterile formats, it complies with the USP monograph for purified water.
Purified Water specific product test requirements and typical values are given below:
| Parameter | Method | Specification |
|---|---|---|
| Appearance | Visual | Clear and Colorless Liquid |
| Conductivity (packaged) | USP <645> | <= 2.1 µS/cm |
| Oxidizable Substances | USP | The pink color does not Completely Disappear |
| TOC (before packaging) | USP <643> | < 500ppb |
