Natamycin
EC Directive 2008/84/EC (Content: ≥95.0%)
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Product Description
Natamycin is a natural antifungal agent that belongs to the group of polyene macrolide produced by Streptomyces natalensis. Natamycin is a crystallized substance that is colorless, odorless and tasteless. Natamycin is very stable so that it can be widely applied in the food industry for more than 30 years.
Characteristics
Ø Nomenclature
• International Nonproprietary Name (INN):Natamycin
• ; Compendial name: Natamycin
• Other synonym: Pimaricin
• Molecular formula: C33H47NO13
• ; Relative molecular mass: 665.73
• ; Company's code: NTA
• Chemical Abstracts Service (CAS) registry number: 7681-93-8
Ø Physico-chemical properties
• White to creamy-white, almost odourless, crystalline powder
• Practically insoluble in water, lipid and mineral oils
• Slightly soluble in methanol; soluble in glacial acetic acid
• ; ; Non-sterile micronized or non-micronized
Ø Biological properties
• Natamycinis active against yeast and moulds, but not bacteria, virus, and other organisms like protozoa.
• Natamycin isthemost effective at pH levels of between 5 and 7while the fungicide’seffectiveness may be reduced by as much as 30%at below pH 4 and above pH 9.
Compliance with Pharmacopoeia and Official Standards
Lifecome Biochemistry Co. regularly supplies both active ingredient of natamycinand formulated form of natamycin (mainly 50%) to comply with customers' needs. However, the company can supply a highly pure product of natamycin, of which contentis more than 98%.
Ø Active ingredient of Natamycinconforms to US Pharmacopoeia 39
• Content of natamycin (drybasis): 90.0%-102.0%
• pH: 5.0-7.5
• ; Water: 6.0%-9.0%
Ø Active ingredient of Natamycinconforms to ECDirective 2008/84/EC
• Content of natamycin (drybasis): ≥95.0%
• pH: 5.5-7.5
• Loss on drying: ≤ 8.0%
• ; Specific rotation: +250-+295(1% w/v solution in glacial acetic acid)
• Sulfated ash: ≤ 0.5%
• Arsenic: ≤ 3mg/kg
• Lead: ≤ 5mg/kg
Ø Active ingredient of Natamycinconforms to ECDirective 2008/84/EC(Continued)
• Mercury: ≤ 1mg/kg
• Heavy metal (as Pb): ≤ 10mg/kg
• Total viable count: ≤ 100cfu/g
Ø End-Use Formulated Natamycinwith Glucose, Lactose, or Sodium Chloride
• Content of natamycin: 50%-55%
• pH: 5.0-7.5
• ; Loss on drying: ≤ 8.0%
• Total viable count: ≤ 100cfu/g
Indication and Application
Ø Natamycin has been used as a natural food preservative for more than 30 years dueto its fungicidal activity against almost all fungi and yeasts. In addition, as natamycin has no antibacterial action, it does not interfere with the food’s natural maturing processes.
Ø Natamycin can be applied on the surface of cheeses or cured meat productsby dipping the product in an aqueous solution of natamycin, or by spraying the aqueous solution around the product. The most common concentration varies between 1,000 and 2,000 ppm.
Ø For agricultural use (bio-pesticide), natamycin is also used tocontrol dry bubble disease caused byVerticillium fungicolain mushroom production facilities.
Regulatory Compliances
Following documents and certificates are available as requested;
Ø EU Drug Master File (DMF) with full impurity profile complies with EMA requirements
Ø Certificates of KOSHER, HALAL, ISO9001, ISO22000, ISO14001, and OHSAS18001
Availability
Ø Non-sterile active ingredient of natamycin(micronized/non-micronized)complieswith USP39 (purity, 90.0%-102.0%), and EC Directive 2008/84/EC (purity, ≥95.0%)isavailable, respectively.
Ø 50% end-use formulations of natamycin with different excipients (Glucose, Lactose, Sodium chloride) are also available. Package sizes of the end-sue formulations are 100g×50 bottles/carton, 500g×10 bottles/carton, and 10 kg/drum, respectively.
Other Information
Ø Self-life is 24 months from the date of manufacture
Ø Protect contents from humidity after opening, store in a dry and cool place
Ø Ultraviolet radiation and oxidants should be avoided
Ø Use of natamycinis an exception to the prohibition on the use of antibiotics in the food industry, as it has no bacterial action
