Key Specifications
Headline parameters — full spec sheet on CoA.
| Parameter | Value | Unit |
|---|---|---|
| Pharmacopoeia | USP/EP/JP | compliant |
| Purity | ≥ 99.0 | % ZnO (USP) |
| Pb | ≤ 50 | ppm (USP) |
| Microbial | ≤ 10² | CFU/g (TAMC) |
Full Specification
CAS 1314-13-2 · EINECS 215-222-5 · Indirect process · Verified Chinese manufacturer.
| Parameter | Value |
|---|---|
| Appearance | Soft, amorphous white or yellowish-white powder |
| Identification (USP) | Passes test |
| ZnO Content (after ignition) | 99.0 – 100.5% (USP) / 99.0 – 100.5% (EP) |
| Loss on Ignition | ≤ 1.0% |
| Acid Insoluble Matter | ≤ 0.005% |
| Lead (Pb) | ≤ 50 ppm (USP) · ≤ 10 ppm (in-house tighter spec) |
| Cadmium (Cd) | ≤ 5 ppm |
| Arsenic (As) | ≤ 3 ppm |
| Iron (Fe) | ≤ 100 ppm (USP) · ≤ 50 ppm (in-house) |
| Alkalinity | Passes test (USP) |
| Carbonate / Substances soluble in ammonia | Passes test |
| D50 | 0.5 – 5 μm (customer-specified) |
| Total Aerobic Microbial Count (TAMC) | ≤ 10² CFU/g |
| Total Yeasts & Molds Count (TYMC) | ≤ 10¹ CFU/g |
| E. coli / Staph. aureus / Pseudomonas | Absent in 1 g |
| Packaging | 25 kg multi-wall paper bag with PE inner liner · double-bagged option for pharma cleanroom |
Application Details
+Calamine Lotion & Topical Skin Care
Dominant active in calamine lotion (typically 8 – 15 wt%). Provides mild astringent and antimicrobial action. Particle size and dispersion control are critical for texture and patient comfort.
+Sunscreen & Sun Care
Physical UV filter (UVA + UVB, broad-spectrum 290 – 400 nm). Used at 2 – 25 wt% per product positioning. Micronized or nano-grade ZnO is more transparent but requires separate cosmetic-grade certification — pharma grade typically uses larger D50 (1 – 5 μm) for visible coverage and full opacity.
+Antifungal & Diaper Rash Cream
Zinc oxide provides barrier function and mild antimicrobial action against Candida and dermatophytes. Common loadings 10 – 40 wt% in barrier creams. Pharma grade ensures no skin sensitizers.
+Dental Materials & Eugenol Cements
ZnO is the powder component in zinc oxide eugenol (ZOE) temporary cement. Requires ZnO ≥ 99.5% with controlled hardness and reactivity to give consistent setting time.
Frequently Asked Questions
+Do you provide GMP / ISO 9001 / ISO 22000 certificates?
ISO 9001 certificate available on request. Active Pharmaceutical Ingredient (API) GMP certification covers the indirect-process source plant for the pharma grade specifically.
+Which pharmacopoeia method do you test against?
Default testing is per current USP monograph (Zinc Oxide). EP and JP testing available on request with the appropriate CoA citation. We can issue a tri-pharmacopoeia CoA showing all three method results on one document for global filings.
+What is the typical particle size and can we order to a specific D50?
Standard pharma grade ships at D50 1 – 3 μm. Custom D50 (0.5 – 5 μm) available with 1 MT MOQ. Sub-micron / nano-grade (D50 < 100 nm) is a separate cosmetic / sunscreen-specific grade — please specify upfront.
+How long is the retest interval?
Retest at 60 months from manufacture date when stored in original sealed packaging at < 30 °C with relative humidity < 70%. ZnO is chemically stable but absorbs atmospheric CO₂ slowly over time, raising loss-on-ignition.