PurifiDE® XG-1, PurifiDE XG-3, and PurifiDE XG-12 Purified Siliceous Earth USP-NF Filter Aids labeled, 'Not intended for use in Pharmaceutical Manufacturing' (NIPM) are recommended for use in the production of delicate food and beverage products, such as nutraceuticals, luxury brands of bourbon and other spirits, and for the filtration of unstable chemicals that are prone to modification by exposure to even low levels of elemental impurities.
Typical uses include:
PurifiDE® XG USP-NF Purified Siliceous Earth (NIPM) are made entirely in the USA from unique low-density DE ores and well-controlled manufacturing processes which include calcination and further purification in a closed facility that follows, at minimum, an ISO 9001:2015 certified Quality Management System and Good Manufacturing Practices. The manufacturing processes yield products which meet the purity standards of the Monograph on Purified Siliceous Earth in the United States Pharmacopeia-National Formulary (USP 40-NF 35). The manufacturing processes also reduce leachable elemental impurities to trace levels (Table 1).
PurifiDE® XG Purified Siliceous Earth USP-NF NIPM products are released for sale after quality control testing in a cGMP compliant QC laboratory. One composite sample is tested from every manufacturing batch (450 kgs) and every test result must meet the requirements of the Monograph on Purified Siliceous Earth (USP 40-NF 35) before release for sale. Tests listed on the C of A for PurifiDE® XG USP-NF Purified Siliceous Earth NIPM are shown in Table 2. Please contact your EP Minerals Sales professional to obtain copies of Certificates of Analysis for PurifiDE XG Purified Siliceous Earth USP-NF NIPM.
Please request quality documents from your EP Minerals sales professional.
PurifiDE XG-1®, PurifiDE XG-3 and PurifiDE XG-12 Purified Siliceous Earth USP-NF (NIPM) are packaged in lined paper bags (Figure 1). Each bag contains 28.7 lbs. (13 kg) net of product and carries a label with details of the contents (Figure 2). Please inquire with your EP Minerals sales professional for additional packaging formats, including bulk-bags.
Figure 1. Lined paper bag containing PurifiDE XG-12 USP-NF Purified Siliceous Earth (Not Intended for use in Pharmaceutical Manufacturing). Each bag contains 28.7 lbs. (13 kg) of product.
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