ZINC OXIDE 112 USP

ZINC OXIDE USP GRADE 112 USP is produced by the French (Indirect) Process and meets the most stringent medicine safety laws and standards in the world including: - API (Active Pharmaceutical Ingredient), - GMP (Good Manufacturing Practices) ICH Q7, - USP, EP, BP and other Compendium Monographs. Grade 112 USP is our most popular USP prescription drug pharmaceutical ingredient product. Grade 112 USP replaces Grades Zinc Oxide LLC USP10, ZOCO 112 USP, and KADOX USP-3.

Principal: Zochem ULC

Chemical Name: Zinc Oxide

Certifications & Compliance: BfR Recommendation, British Pharmacopeia (BP), European Pharmacopeia (Ph. Eur.), FDA 21 CFR 175.105, FDA 21 CFR 175.300, FDA 21 CFR 175.320, FDA 21 CFR 176.170, FDA 21 CFR 176.180, FDA 21 CFR 177.1010, FDA 21 CFR 177.2600, FDA 21 CFR 182.8991, FDA Compliant, GB 9685-2016, GMP, Generally Recognized As Safe (GRAS), Health Canada Approved, ICH Q7, JHOSPA Registered, Japan Ministry of Health, Labor and Welfare (MHLW), Kosher, MERCOSUR GMC Resolution 39/19, REACH (Europe), Regulation (EU) No. 10/2011 (PIM), United States Pharmacopeia (USP)

Labeling Claims: Animal Products-free, Halal, Kosher, Nanomaterials-free, Pareve

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Enhanced TDS

Identification & Functionality

Blend
No
Chemical Family
Chemical Name
Country of Origin
Pharma & Nutraceuticals Functions
Product Code
MITM10082
Single Ingredient
Yes
Synonyms
Hubbuck's White, Zinc gelatin, Zinc monoxide, Zinc white, ZnO
Technologies
Product Families

Features & Benefits

Properties

Regulatory & Compliance

Packaging & Availability

Packaging Type
Packaging Information

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

Principal Information

Group Principal Number
S002011
Principal

Other

Appearance (SDS)
Solid, powder or pellet/granular
Color (SDS)
White, off white, cream, grayish, or yellowish.
Flammability Class (SDS)
Not flammable. Will not burn.
Insoluble in (SDS)
Water
Item Number
Odor (SDS)
Odorless
Physical Properties
ValueUnitsTest Method / Conditions
Moisture Contentmax. 1.0 %%USP Method at 500°C
Sieve Fractionation (Retained)max. 0.01 %%ASTM D185 325 mesh
Sieve Fractionation (Through)min. 99.99 %%ASTM D185 325 mesh
Specific Surface Area3.0-6.5 m²/gm²/gASTM D4315
Material Composition
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 6.0 ppmppmInductively Coupled Plasma (ICP)
Cadmium Contentmax. 0.001 %%ASTM D4315
Iron Contentmax. 0.002 %%ASTM D79
Lead Contentmax. 0.002 %%ASTM D4315
Zinc Oxide Content99.0-100.5 %%USP Method
SDS Physical and Chemical Properties
ValueUnitsTest Method / Conditions
Median Particle Size (SDS)1.05 µmµmD50
Molecular Weight (SDS)81.38 g/molg/mol
Relative Density (SDS)5.68-
Sublimation Point (SDS)197.5 °C°C
pH (SDS)6.8-8.0-7.37 nominal