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CHIHONBIO LOG

NATAMYCIN THAT COMPLIANCE WITH USP

CHIHONBIO

NATAMYCIN USP42


INS:235

Molecular weight:665.73

Molecular formula :C20H41N4O3Cl

Molecular structural:

Natamycin

Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis. It possesses in vitro activity against a variety of yeast and filamentous fungi, including Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium. The mechanism of action appears to be through binding of the molecule to the sterol moiety of the fungal cell membrane. The polyenesterol complex alters the permeability of the membrane to produce depletion of essential cellular constituents. Although the activity against fungi is dose-related, natamycin is predominantly fungicidal. Natamycin is not effective in vitro against gram-positive or gram-negative bacteria. Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. NATAPRO standard item compliance with USP42, Suitable for the preparation of eye drops, skin ointment and other drug.

STANDARD

 

?Items

Standard

Description

White to creamy-white powder and odorless

Identification

Complies with the requirements

Solubility

Pratically insoluble in water; slightly soluble in Methanol; soluble in Acetic acid and in Dimethylformamid.

Assay(On dried basis)

≥95.0%

pH(1%aqueous solution)

5.5~7.5

Loss on drying

≤8.0%

Ash

≤0.5%

Heavy metals(Total as Pb)

≤10mg/Kg

Arsenic

≤3mg/Kg

Lead

≤2mg/Kg

Mercury

≤1mg/Kg

Particle size

100% less then 10μm

Residual solvent Ethonal

≤0.5%

Total plate count

≤100cfu/g

Salmonella

25g Negative

Listeria monocytogenes

25g Negative

Specific rotation

+250°~+295°

package

■ 1kg/bottle ,10 bottles/carton


NATAPRO USP42

NATAPRO USP

NATAPRO L50

NATAPRO L50

NATAPRO G30

NATAPRO G30

NATAPRO G4.0

NATAPRO G4.0


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