Zochem Zochem Zochem’s Grade 112USPL:
Grade 112USPL offers ultra-low lead (the lowest lead attainable), and is used where the lowest lead is required and standard Grade 112USP is not suitable in the application.
Grade 112USPL is also available in an API (Active Pharmaceutical Ingredient) version “Grade 112USPL (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 112USPL” or “Grade 112USPL (API)”
Chemical Analysis (%) | Typical Limit** | Nominal | Test Method |
|---|---|---|---|
| Zinc Oxide (ZnO) Assay* | 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 |
Chemical Analysis (%) | Typical Limit** | Nominal | Test Method |
|---|---|---|---|
| Surface Area (m2/g)* | 3.0 – 6.5 | 5 | ASTM D4315 |
| Lead as Pb (%) | 0.001 max | 0.0008 | ICP or AA |
| Cadmium as Cd (%) | 0.0003 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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