Palmer Holland - ZINC OXIDE USP GRADE 103 USP - FDA Compliant

Enhanced TDS

Identification & Functionality

Blend: No
Chemical Family: Zinc & Zinc Compounds
Chemical Name: Zinc Oxide
Country of Origin: United States of America (USA)
Product Code: MITM09281
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

Generally Recognized As Safe (GRAS),

Not Listed In California Proposition 65,

Odor-free,

Kosher,

Pareve,

Animal Products-free,

Halal,

Nanomaterials-free

Key Features

Zochem offers several FDA approved grades:

103 USP (low 2-4 m2/g surface area “SA”),
112 USP (medium SA),
101 USP (higher 6-8.5 SA),
102 USP (highest 8-10 SA),
112 EP-BP (European Union/British

Pharmacopeia), the proper API GMP pharma grade for use outside the U.S.A.

104 is USFDA approved as GRAS (Generally Recognized As Safe) at 21cfr73.8991 and used for OTC, excipient (inactive ingredient) and wherever an FDA approved grade is required.

Properties

Physical Form: Pellets,
Powder,
Granules
Soluble In: Acid Soluble

Regulatory & Compliance

Certifications & Compliance: Regulation (EU) No. 10/2011 (PIM),
GMP,
MERCOSUR GMC Resolution 39/19,
ICH Q7,
Kosher,
Health Canada Approved,
FDA 21 CFR 175.320,
FDA 21 CFR 177.1010,
FDA 21 CFR 176.180,
FDA 21 CFR 182.8991,
Generally Recognized As Safe (GRAS),
FDA 21 CFR 175.300,
Japan Ministry of Health, Labor and Welfare (MHLW),
REACH (Europe),
FDA 21 CFR 175.105,
BfR Recommendation,
FDA 21 CFR 177.2600,
FDA 21 CFR 176.170,
FDA Compliant,
GB 9685-2016,
JHOSPA Registered
Contains any chemicals listed on Prop 65 (including impurities, residues, catalysts, monomers, and by-products and excluding heavy metals)?: No
Quality Standards: EN ISO 9001:2015,
ICH Q7,
GMP,
United States Pharmacopeia (USP),
European Pharmacopeia (Ph. Eur.),
British Pharmacopeia (BP),
ISO 14001

Packaging & Availability

Packaging Type

Bags,

Super Sacks

Packaging Information

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

Principal Information

Group Principal Number: S002011
Principal: Zochem ULC

Other

Appearance

Clear and colorless solution

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

USA/DOT UN Number

Not Applicable

Physical Properties


	Value	Units	Test Method / Conditions
Moisture Content	max. 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 Area	2.0-4.0 m²/g	m²/g	ASTM D4315

Material Composition


	Value	Units	Test Method / Conditions
Arsenic Content	max. 6.0 ppm	ppm	Inductively Coupled Plasma (ICP)
Cadmium Content	max. 0.01 %	%	ASTM D4075
Iron Content	max. 0.02 %	%	ASTM D4075
Zinc Oxide Content	99.0-100.5 %	%	USP Method

SDS Physical and Chemical Properties


	Value	Units	Test Method / Conditions
Median Particle Size (SDS)	1.05 µm	µm	D50
Molecular Weight (SDS)	81.38 g/mol	g/mol
Relative Density (SDS)	5.68	-
Sublimation Point (SDS)	197.5 °C	°C
pH (SDS)	6.8-8.0	-	7.37 nominal