Products Description Is a highly active enzyme preparation derived from the porcine pancreas gland that contains Protease, Amylase and Lipase. Enzymatic Properties The optimum pH for the Protease is 7.4 to 8.2, the Amylase pH is 8.0, and the Lipase pH is 7.0 to 8.0. The optimum temperature for the Protease is 40° C, the Amylase optimum temperature is 40°C and the Lipase optimum temperature is 37°C. Activity The activity for the Protease, Amylase and Lipase are done according to the USP methods. The acceptance criteria for all enzyme assays is: NLT 85.0% and NMT 115.0% of the declared units of enzyme activity.* Basic Analysis Analysis Description Test Method Activity Protease USP Amylase USP Lipase USP Identity Pancreatin FTIR Moisture NMT 10% Ohaus MB-45 Arsenic (As) < 2 ppm ICP-MS/AOAC 993.14 Cadmium (Cd) < 2 ppm ICP-MS/AOAC 993.14 Lead (Pb) < 2 ppm ICP-MS/AOAC 993.14 Mercury (Hg) < 0.5 ppm ICP-MS/AOAC 993.14 Microbial Analysis TPC <10,000 CFU/g Soleris / AOAC 990.12 E.coli Negative/10g Soleris / AOAC 991.14 Entero <100 CFU/g AOAC 2003.01 Salmonella Negative/25g BAM Ch. 5 / AOAC 2011.03 Yeast <1,000 CFU/g Soleris / AOAC 997.02 Mold <1,000 CFU/g Soleris / AOAC 997.02 Coliforms <100 CFU/g Soleris / AOAC 991.14 Gmo statement We hereby declare that, to the best of our knowledge, this product was not produced from or with GMO plant material. Ingredient statement Statement Option #1: Pure Single Ingredient This 100% single ingredient does not contain or use any additives, preservatives, carriers and/or processing aids in its manufacturing process. Statement Option #2: Multiple Ingredients Must include all/any additional sub ingredients contained in and/or used in its manufacturing process. Gluten free statement We hereby declare that, to the best of our knowledge, this product is gluten-free and was not manufactured with any ingredients containing gluten. (Bse)/ (Tse) Statement We hereby confirm that, to the best of our knowledge, this product is free of BSE/TSE. Cruelty-free statement We hereby declare that, to the best of our knowledge, this product has not been tested on animals. Kosher statement We hereby confirm that this product has been certified to Kosher standards. Vegan Statement We hereby confirm that this product has been certified to Vegan standards. Food Allergen Information ALLERGENS PRESENCE ABSENCE PROCESS COMMENT Milk or milk derivatives No Yes No Egg or egg derivatives No Yes No Fish or fish derivatives No Yes No Shellfish, crustaceans, mollusks & their derivatives No Yes No Peanuts or peanut derivatives No Yes No Tree nuts or their derivatives No Yes No Soy or soy derivatives No Yes No Wheat or wheat derivatives No Yes No Trans Fat This product does not contain any trans fats.