French Process Zinc Oxide . Grade 101USPL

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DESCRIPTION

  • 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 101USPL offers ultra-low lead (the lowest lead attainable), with medium m2/g surface area (SA) and is used where the lowest lead and higher SA is required and standard Grade 112USP is not suitable in the application.

Grade 101USPL is also available in an API (Active Pharmaceutical Ingredient) version “Grade 101USPL (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 101USPL” or “Grade 101USPL (API)”

REPRESENTATIVE CHEMICAL PROPERTIES
Chemical Analysis (%)
Typical Limit**
Nominal
Test Method
Zinc Oxide (ZnO) Assay*99.0% – 100.5%99.7%Titration
Arsenic (As)6 ppm max0 ppmICP or USP monograph
Loss on Ignition at 500° C1.0% max0.2%USP monograph
AlkalinityFinal solution is not redPassUSP monograph
Lead (Pb)No Turbidity or precipitatePassUSP monograph
Iron (Fe) & Other Heavy MetalsWhite precipitates are formedPassUSP monograph
Carbonate & Color of SolutionClear, colorless, no effervescencePassUSP monograph
Identification A (ID A)Turns yellow when heated dissipates when cooledPassUSP monograph
Identification of zinc (ID B replacement)*Response as zincPassAA, ICP-OES, or acid insol wht precipitate
REPRESENTATIVE PHYSICAL PROPERTIES
Chemical Analysis (%)
Typical Limit**
Nominal
Test Method
Surface Area (m2/g)*6.0 – 8.57ASTM D4315
Lead as Pb (%)0.001 max0.0008ICP or AA
Cadmium as Cd (%)0.0003 max0.0002ICP or AA
Iron as Fe (%)0.002 max0.0003ICP or AA
Fineness retained on 325 mesh (%)0.03 max0.008ASTM D4315
AppearanceFine white powderPassSupplier

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 12 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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