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发布日期:2021年10月17日
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Several blister packs and vials in a medicine cabinet
USP

Popular USP Zinc Oxide Applications:

  • Sunscreens – UV protection in natural formulas requiring
    a non-nano option
  • Diaper rash creams and wound care – promotes healing
  • Nutritional supplements – vitamins and mineral premixes
  • Cosmetics – UV protection for outdoor applications
  • Lotions, creams and toothpaste
  • Calamine and other lotions

Other Common Applications:

  • Dental creams
  • Toothpaste
  • Food and medical packaging
  • Medical equipment
  • Medical tapes
  • Pharmaceutical (Chemical intermediate)
  • Vitamins
  • Dog Food

Zochem Grade 112USP, 112 EP-BP Recommended

Zochem Zinc Oxide FDA and USP
Four Product Type Options

1. USP

  • Manufactured in an FDA-registered food manufacturing facility
  • Produced by the French (Indirect) Process
  • Meets USP Compendium Monograph specification for zinc oxide
  • Meets GMP (Good Manufacturing Practices) 21 CFR110 for food and excipients
  • Meets IPEC/ANSI/NSF 363 GMP standard for excipients
  • Manufactured in an FDA-registered drug establishment manufacturing facility, which has been inspected by the FDA and/or Health Canada, who have certified both Zochem facilities as compliant with ICH-Q7 GMP for API

Zochem Grade 112USP Recommended

2. USP API (Active Pharmaceutical Ingredient)

  • Manufactured in an FDA-registered drug establishment manufacturing facility, which has been inspected by the FDA as compliant with ICH-Q7 GMP for API
  • Meets ICH-Q7 GMP and 21 CFR211 cGMP for API for pharmaceutical drug product and USP (API) grade products
  • Meets 21 CFR111 GMP for dietary supplements (DS)
  • For use when zinc oxide is an active ingredient in a prescription-only drug, such as a high-potency prenatal vitamin
  • Available for customer API specifications

Zochem Grade 112USP Recommended

3. L Series (L for Ultra-low Lead)

  • Available in either USP or USP (API) registrations and GMP
  • Offers the lowest lead (Pb) level attainable, where clients request impurity levels better than USP monograph specification limits
  • Meets FCC (Food Chemical Codex) model standards
  • 10 PPM max lead

Zochem Grade 112 USPL or 112 USPL (API) Recommended

4. FDA Approved

For 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)
  • Plastics at 21 CFR177.1010(a) and 1010(b) (1)
  • Food can liner and coatings at 21 CFR175.300(b)(2)
  • Animal drugs, feeds, nutrient products and/or dietary supplements at 21 CFR582

Zochem Grade 102 (plastics), 500 (coatings), 400 (rubber) Recommended

Other Country USFDA GRAS equivalent regulations and approvals include:

  • Canada (Zochem has received a no-objection letter from Canada EU member states at EU 1-/2011 and EC 1935/2004
  • Mercosur (South America) Positive List RD 39/19 Table 1
  • Japan JHOSPA and MHLW meets assay requirements and impunity limits
  • China GB 9685-2016

Zochem Grade 102 (plastics), 500 (coatings), 400 (rubber) Recommended