Basic Info
This medicine and food grade iron oxide black colorant is specially developed for pharmaceutical sugar coating, food packaging and nutritional supplement coloring. It meets global mainstream food and drug safety standards, solving the pain point of excessive heavy metals and microbial contamination of ordinary colorants, targeting pharmaceutical enterprises, food packaging manufacturers and nutritional health product manufacturers.
Customer reviews
Sarah · Food Additives Quality Controller
The medicine & food grade iron oxide black meets all our strict safety requirements (FDA 21 CFR 73.1200 compliant). We use it in capsule coatings where color consistency is critical - every batch tests within ΔE<0.5. The microbiological counts consistently come in below 100 CFU/g, and heavy metal content is undetectable. It blends perfectly with our other excipients without causing any processing issues in our tablet presses.
Product Description
Product features:
Adopting high-purity raw materials and refining process, the colorant has heavy metal and microbial content far lower than industry standards. It is treated by high-temperature sterilization, with excellent chemical stability, and will not discolor or precipitate in acid-base environments. It can be directly used for coloring food contact products, passes FDA and EU authoritative certifications, and is safe and reliable.

Product specifications:
Detailed technical parameters include: iron oxide content ≥99.5%, particle size 1-3μm, pH value 6.5-7.5, moisture content ≤0.3%, lead, cadmium and arsenic content ≤1ppm, total microbial colony count ≤10 CFU/g, insoluble in water and ethanol, no discoloration at 250℃. The net weight per drum is 5kg, sealed with food-grade polyethylene plastic drum, meeting food transportation safety standards.

Product application:
It is mainly used in pharmaceutical sugar coating coloring, health care product capsule shell coloring, food packaging printing ink, children's tableware surface coloring and other scenarios. It can be used as a safe and compliant black colorant, meeting the strict safety requirements of the pharmaceutical and food industry.
Frequently Asked Questions (FAQ)
Q:What are the key applications of Medicine & Food Grade Iron Oxide Black Colorant?
A:Medicine & Food Grade Iron Oxide Black (E172) is primarily used as a safe coloring agent in pharmaceuticals (tablet coatings), dietary supplements, and food products like candies or baked goods. It meets FDA/EFSA standards for purity (<3ppm heavy metals).
Q:How does Medicine & Food Grade Iron Oxide Black differ from industrial-grade?
A:Food-grade (Fe3O4) undergoes strict purification to remove heavy metals/impurities (arsenic <3mg/kg, lead <10mg/kg), while industrial-grade may contain contaminants. Particle size is also controlled at 0.1-1μm for uniform dispersion in edibles.
Q:Is Medicine & Food Grade Iron Oxide Black heat-stable in food processing?
A:Yes, it maintains color integrity up to 300°C, making it suitable for baked goods and sterilized pharmaceuticals. Its inert nature prevents reactions with other ingredients during high-temperature processing.
Q:What is the recommended dosage of Iron Oxide Black in food products?
A:Typical usage is 0.1-1% by weight, varying by application. Confectionery may use 0.5%, while tablet coatings often require <0.3%. Always comply with local regulations (EU: max 0.1g/kg in most foods).
Q:How to verify the authenticity of Food Grade Iron Oxide Black?
A:Check for certifications: USP/NF, FCC, or EU E172 compliance. Authentic products provide COA (Certificate of Analysis) with purity ≥96%, arsenic <1ppm, and microbial limits (<1000 CFU/g). Supplier should offer batch-specific documentation.