E235 · CAS 7681-93-8

Natamycin 95%

Natamycin 95% is the high-purity crystalline form of the tetraene macrolide antifungal, sold without any food-grade carrier. It is the pharmacopoeia-grade material from which the diluted food formats are blended.

The grade is reserved for pharmaceutical formulation, ophthalmic suspension manufacture, and high-concentration surface sprays where carrier-free active is required and where pharmacopoeia identity, purity, and assay testing apply.

We source bulk Natamycin 95% from top China manufacturers for our partners, working with several of them. The manufacturers are mostly in Henan, Shandong and Jiangsu. A smaller requirement can ship in a combined container with other ingredients.

Please send the grade you need, the volume and your destination port, and we will come back with a solution and a price.

or call +86-21-6858 0751

Natamycin 95%
Packaging
20 kg fibre drum with double PE liner
  • ISO 9001
  • HACCP
  • Halal
  • Kosher

Specifications

Grades / Types Available: Food Grade

ItemSpecification
AppearanceWhite to cream-colored crystalline powder
Assay (as Natamycin)≥ 95.0%
Moisture≤ 6.0%
Specific Rotation [α]D20+250° to +295°
pH (1% suspension)5.0 - 7.5
Residue on Ignition≤ 0.5%
Total Plate Count≤ 50 CFU/g
Yeasts & Molds≤ 10 CFU/g
Heavy Metals (as Pb)≤ 10 mg/kg
Lead (Pb)≤ 2 mg/kg
Purity/Assay> 95%
Melting point150 °C
ViscosityNo information available

Common Markets Grades

This grade is specified at 95.0 percent natamycin minimum on the anhydrous basis, with water content typically reported separately.

The material is a pale cream to off-white fine crystalline powder. Particle size is controlled to the micron range required for suspension preparation in eye drops and topical formulations.

A 50 percent variant on glucose, lactose, or sodium chloride carrier is produced for food applications where a high-purity carrier-free product would be impractical to dose. Those carrier grades are listed separately.

Applications

  • Ophthalmic suspension manufacture, most notably 5 percent natamycin eye drops for fungal keratitis
  • Topical antifungal creams, lotions, and gels at 1 to 2 percent active concentration
  • Vaginal pessaries and intravaginal creams in markets where the indication is registered
  • Otic suspension for outer-ear fungal infections
  • Aqueous surface spray for cheese and sausage where lower-carrier active is preferred
  • Veterinary topical preparations for mycotic dermatitis
  • Reference standard for analytical laboratories testing finished food products
  • Pilot-scale pharmaceutical development and clinical trial material
  • Research use in microbiology to suppress fungal contamination of bacterial cultures
  • Custom blending into proprietary food preservative systems
  • Aquaculture trial preparations for fungal infections of fish eggs
  • Surface decontamination spray for ripening room walls and equipment

How We Help Source Natamycin 95%

  • Direct Factory Sourcing

    We run the whole process: selecting the manufacturer from the top Chinese food ingredient producers, negotiating the price, verifying quality, and coordinating the logistics. You deal with us instead of with several factories at once.

  • Original Packaging and Documents from the Manufacturer

    The manufacturer sends your Natamycin 95% out of its own factory in the original packing, through to your destination port. The COA, COO, MSDS, TDS and any certifications reach you from the manufacturer as well.

  • Free Samples and Lead Time

    We send 100 to 500 g free for your own laboratory to test and you cover only the courier, usually within 2 to 3 working days. ETD is usually within 7 to 15 days once the order is confirmed, and we check that date against the factory's own manufacturing schedule before we give it to you.

  • Combined Shipment

    We can load Natamycin 95% together with other ingredients such as Calcium Propionate, Sodium Diacetate and Sodium Propionate into one 20' FCL. If your quantity is small, we can also ship LCL.

Regulatory Status

Natamycin at this purity is principally a pharmaceutical and pharmacopoeia-grade material. Monographs appear in the United States Pharmacopeia under Natamycin, in the European Pharmacopoeia under Natamycinum, and in the British Pharmacopoeia.

For ophthalmic use the relevant U.S. monograph is Natamycin Ophthalmic Suspension USP. The active is the subject of an approved U.S. New Drug Application for topical ophthalmic treatment of fungal keratitis.

For food applications the European Union restricts the same active to surface treatment of cheese and dried cured sausage under E235, and 21 CFR 172.155 restricts it to cheese surface use in the United States. Use of a carrier-free 95 percent grade in food is technically possible but uncommon, as the practical difficulty of dosing micrograms of insoluble powder favours the 50 percent carrier blends in food settings.

Halal, Kosher, and pharmaceutical good manufacturing practice certifications are routinely available subject to facility scope.

Manufacturing Process

The active is produced by aerobic submerged fermentation of Streptomyces natalensis on a defined medium containing glucose, soy peptone, and yeast extract.

After fermentation, the broth is filtered to remove biomass. The antifungal is extracted into a polar solvent such as methanol, then crystallised out by cooling and pH adjustment.

The crude crystals are washed with water and recrystallised one or more times to remove residual fermentation impurities. The recrystallised material is dried under vacuum to a defined water content and milled to the specified particle size.

Final material is assayed by ultraviolet absorption at 303 nm against a reference standard and tested for related substances by high-performance liquid chromatography. Specifications align with the United States Pharmacopeia and European Pharmacopoeia monographs for natamycin.