USP grades must meet or exceed the industry’s highest standards for product quality and testing. Zochem offers 9 unique grades, all certified by agencies of their intended applications.
Sunscreens – UV protection in natural formulas requiring a non-nano option
Grade 112USP Recommended Grade 112EP RecommendedDiaper rash creams and wound care – promotes healing
Grade 112USP Recommended Grade 112EP RecommendedNutritional supplements – vitamins and mineral premixes
Grade 112USP Recommended Grade 112EP RecommendedManufactured in an FDA-registered food manufacturing facility
Grade 112USP RecommendedProduced by the French (Indirect) Process
Grade 112USP RecommendedMeets USP Compendium Monograph specification for zinc oxide
Grade 112USP RecommendedMeets GMP (Good Manufacturing Practices) 21 CFR110 for food and excipients
Grade 112USP RecommendedMeets IPEC/ANSI/NSF 363 GMP standard for excipients
Grade 112USP RecommendedManufactured in an FDA-registered drug establishment manufacturing facility, which has been inspected by theFDA and/or Health Canada, who have certified both Zochem facilities as compliant with ICH-Q7 GMP for API
Grade 112USP RecommendedManufactured in an FDA-registered drug establishment manufacturing facility, which has been inspected by the FDA as compliant with ICH-Q7 GMP for API
Grade 112USP RecommendedMeets ICH-Q7 GMP and 21 CFR211 cGMP for API for pharmaceutical drug product and USP (API) grade products
Grade 112USP RecommendedMeets 21 CFR111 GMP for dietary supplements (DS)
Grade 112USP RecommendedMeets 21 CFR111 GMP for dietary supplements (DS)
Grade 112USP RecommendedAvailable for customer API specifications
Grade 112USP RecommendedFor use when zinc oxide is an active ingredient in a prescription-only drug, such as a high-potency prenatal vitamin
Grade 112USP RecommendedAvailable in either USP or USP (API) registrations and GMP
Grade 112USPL RecommendedOffers the lowest lead (Pb) level attainable, where clients request impurity levels better than USP monograph specification limits
Grade 112USPL RecommendedMeets FCC (Food Chemical Codex) model standards
Grade 112USPL Recommended10 PPM max lead
Grade 112USPL RecommendedFor all Zochem zinc oxide grades, “Product is USFDA approved as GRAS (Generally Recognized as Safe) at 21 CFR182.8991, meets GMP 21 CFR110, and authorized by the FDA for use wherever GRAS is approved,” including:
Rubber articles at 21 CFR177.2600(c)(1)
Grade 400 RecommendedAnimal drugs, feeds, nutrient products and/or dietary supplements at 21 CFR582
Grade 500 RecommendedPlastics at 21 CFR177.1010(a) and 1010(b) (1)
Grade 102 RecommendedFood can liner and coatings at 21 CFR175.300(b)(2)
Grade 500 RecommendedMercosur (South America) Positive List RD 39/19 Table 1
Canada (Zochem has received a no-objection letter from Canada EU member states at EU 1-/2011 and EC 1935/2004
Japan JHOSPA and MHLW meets assay requirements and impunity limits
China GB 9685-2016
Grade 102 (Plastics), 500 (coatings), 400 (rubber) recommended
Zochem Grade 102 (plastics), 500 (coatings), 400 (rubber) Recommended