French Process Zinc Oxide . Grade 112USP

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DESCRIPTION

Zochem’s Grade 112USP:

  • 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) 21cfr110 for Food and excipients, and IPEC/ANSI/NSF 363 for excipients.

Grade 112USP is our most popular USP product. This grade replaces Grades ZOCO 112USP and KADOX USP-3.

Grade 112USP is also available in an API (Active Pharmaceutical Ingredient) version “Grade 112USP (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 112USP” or “Grade 112USP (API)”

REPRESENTATIVE CHEMICAL PROPERTIES
Chemical Analysis (%)
Typical Limit**
Nominal
Test Method
Zinc Oxide (ZnO) ignited basis 99.0% – 100.5% 99.7% Titration
Arsenic (As) 6 ppm max 0 ppm ICP or USP monograph
Loss on Ignition at 500° C 1.0% max 0.2% USP monograph
Alkalinity Final solution is not red Pass USP monograph
Lead (Pb) No Turbidity or precipitate Pass USP monograph
Iron (Fe) & Other Heavy Metals White precipitates are formed Pass USP monograph
Carbonate & Color of Solution Clear, colorless, no effervescence Pass USP monograph
Identification A (ID A) Turns yellow when heated, dissipates when cooled Pass USP monograph
Identification of zinc (ID B replacement)* Response as zinc Pass AA, ICP-OES, or acid insol wht precipitate
REPRESENTATIVE PHYSICAL PROPERTIES
Chemical Analysis (%)
Typical Limit**
Nominal
Test Method
Surface Area (m2/g)* 3.0 – 6.5 5 ASTM D4315
Lead as Pb (%) 0.002 max 0.0015 ICP or AA
Cadmium as Cd (%) 0.001 max 0.0002 ICP or AA
Iron as Fe (%) 0.002 max 0.0003 ICP or AA
Fineness retained on 325 mesh (%) 0.015 max 0.003 ASTM D4315
Appearance Fine white powder Pass Supplier

Product meets all USP monograph limits.

*Zochem test methods for ZnO Assay, arsenic (by ICP), and Identification of Zinc, have been determined suitable under actual conditions of use for product to meet USP acceptance criteria. Shelf life 18 months from date of manufacturing.

Standard Packaging: 50 lb. Kraft paper bags on 2,000 to 2,500 net wt. pallet unit, or 2,000 lb FIBC.

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