French Process Zinc Oxide . Grade 112EP

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  • Manufactured in an FDA registered food manufacturing facility
  • Produced by the French (Indirect) Process
  • Meets EP Compendium Monograph specification for zinc oxide
  • Meets GMP (Good Manufacturing Practices) 21cfr110 for Food and excipients, and IPEC/ANSI/NSF 363 for excipients

Grade 112EP is used in the European Union (EU) and wherever an internationally recognized pharma grade zinc oxide is required. This grade replaces Grades ZOCO 112USP-EP and Zinc Oxide LLC Grade EP.

Grade 112EP is also available in an API (Active Pharmaceutical Ingredient) version “Grade 112EP (API)” manufactured in an FDA registered drug establishment manufacturing facility which has been inspected by the FDA as compliant with ICH-Q7 GMP for API. The API version also meets 21cfr111 GMP for Dietary Supplements (DS). When ordering, please specify standard “Grade 112EP” or “Grade 112EP (API)”

Chemical Analysis (%)
Typical Limit**
Test Method
Zinc Oxide (ZnO) Assay* 99.0% – 100.5% 99.7% EP monograph
Loss on Ignition at 500° C 1.0% max 0.2% EP monograph
Lead (Pb) 10 ppm max 9 ppm EP monograph
Cadmium (Cd) 5 ppm max 2 ppm EP monograph
Iron (Fe) 200 ppm max 2 ppm EP monograph
Thallium 5 ppm max 0 ppm EP monograph
Alkalinity Final solution is not red Pass EP monograph
Carbonate and substances insoluble in acids Clear, colorless, no effervescence Pass EP monograph
Identification A Turns yellow when heated, dissipates when cooled Pass EP monograph
Identification B Response as zinc Pass EP monograph
Chemical Analysis (%)
Typical Limit**
Test Method
Surface Area (m2/g)* 3.0 – 6.5 5 ASTM D4315
Fineness retained on 325 mesh (%) 0.02 max 0.008 ASTM D185
Appearance Fine white powder Pass Supplier

Shelf life 18 months from date of manufacturing.

Standard Packaging 25 kg. Kraft paper bags on 1000 kg to 1250 kg net wt. pallet unit, or 1000 kg FIBC.

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