ZINC OXIDE 102 USP

ZINC OXIDE USP GRADE 102 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. ZINC OXIDE USP GRADE 102 USP offers the highest m²/g surface area (SA) available with high-quality French Process material, and is used when standard grade 112 USP is not suitable in the application. ZINC OXIDE USP GRADE 102 USP replaces Grades ZOCO 102 USP (Std) and KADOX USP-1.

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

Safety Data SheetTechnical Data Sheet
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Enhanced TDS

Identification & Functionality

Blend
No
Chemical Family
Zinc & Zinc Compounds
Chemical Name
Zinc Oxide
Country of Origin
United States of America (USA)
Pharma & Nutraceuticals Functions
OTC
Product Code
MITM10716
Single Ingredient
Yes
Synonyms
Hubbuck's White, Zinc gelatin, Zinc monoxide, Zinc white, ZnO
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors
Active Pharmaceutical Ingredients (APIs)

Features & Benefits

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

Properties

Soluble In
Acid Soluble

Regulatory & Compliance

Certifications & Compliance
Kosher,
FDA 21 CFR 177.2600,
MERCOSUR GMC Resolution 39/19,
FDA 21 CFR 176.180,
FDA 21 CFR 182.8991,
European Pharmacopeia (Ph. Eur.),
GMP,
United States Pharmacopeia (USP),
British Pharmacopeia (BP),
ICH Q7,
Generally Recognized As Safe (GRAS),
FDA Compliant,
FDA 21 CFR 176.170,
FDA 21 CFR 175.105,
REACH (Europe),
Japan Ministry of Health, Labor and Welfare (MHLW),
FDA 21 CFR 175.300,
FDA 21 CFR 177.1010,
GB 9685-2016,
BfR Recommendation,
Health Canada Approved,
FDA 21 CFR 175.320,
Regulation (EU) No. 10/2011 (PIM),
JHOSPA Registered
Quality Standards
EN ISO 9001:2015,
ISO 14001

Packaging & Availability

Packaging Type
Bags
Packaging Information

ZINC OXIDE USP GRADE 102 USP is available in 50 lb. Kraft paper bags on 2,000 to 2,500 lb net weight pallet units, or 2,000 lb FIBC.

Principal Information

Group Principal Number
S002011
Principal
Zochem ULC

Other

Appearance (SDS)
Solid, powder or pellet/granular
Color (SDS)
White, off white, cream, grayish, or yellowish.
Insoluble in (SDS)
Water
Item Number
ITM23202,
ITM17142
Odor (SDS)
Odorless
USA/DOT UN Number
Not Applicable
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 Area8.0-10.0 m²/gm²/gASTM D4315
Material Composition
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 6.0 ppmppmInductively Coupled Plasma (ICP)
Cadmium Contentmax. 0.001 %%ASTM D4075
Iron Contentmax. 0.002 %%ASTM D4075
Lead Contentmax. 0.002 %%ASTM D4075
Zinc Oxide Content99.0-100.5 %%USP Method
SDS Physical and Chemical Properties
ValueUnitsTest Method / Conditions
Initial Boiling Point (SDS)2450.0 °C°C
Malleability Temperature (SDS)300.0 °C°C
Median Particle Size (SDS)1.05 µmµmD50
Melting Point (SDS)660.0 °C°C
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