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Product Description

Bacitracin Zinc is the zinc complex of bacitracinswhich consist of closely related antimicrobial polypeptides produced by Bacillus licheniformis.Bacitracin A, B₁, B₂ and B₃are major active components in Bacitracin Zinc, among which bacitracin A is the most active component.

Characteristics

Ø        Nomenclature

•  ; ;        International Nonproprietary Name (INN): Bacitracin Zinc

•           Compendial name: Bacitracin zinc

•           Molecular formula: [C₆₆H₁₀₃N₁₇O₁₆S]·nZn

•   ;        Relative molecular mass: 1486-1551

•           Company's code: BZC

•          ; Chemical Abstracts Service (CAS) registry number: 1405-89-6

Ø        Physico-chemical properties

•     ;      Creamy white hygroscopic amorphous powder

•    ;       Slightly soluble in water and in 96% ethanol

•           Sterility: Non-sterile micronized or non-micronized

•           Isoelectric point of bacitracin: 8.5

Ø        Biological properties

•           Antimicrobial effect on Gram-positive bacteria but little activity against Gram-negative organisms

Compliance with Pharmacopoeia

Lifecome Biochemistry Co. regularly supplies different grades of bacitracin zinc, whose main difference is microbiological activity per mg of bacitracin zinc, to comply with customers' needs. However, the company can supplya highly pure product of bacitracin zinc, of which microbiological assay is more than 80 IU/ mg.

Ø        Bacitracin Zinc conforms to US Pharmacopoeia 39

•       ;    Microbiological assay (dry basis): ≥65IU/mg

•           Content of bacitracin A: ≥40.0%

•           Content of active bacitracin (A, B₁, B₂, and B₃): ≥70.0%

•           Limit of early elution peptides: ≤ 20.0 %

•       ;    Limit of bacitracin F: ≤ 6.0 %

Ø        Bacitracin Zinc conforms to EU Pharmacopoeia 9.0

•           Microbiological assay (dry basis): ≥60 IU/mg

•           Content of bacitracin A: ≥ 40.0%

•           Sum of bacitracin A, B₁, B₂, and B₃: ≥ 70.0%

•           Related peptides: ≤ 20.0 %

•           Content of impurity E: ≤ 6.0%

Ø        Bacitracin Zinc conforms to US Pharmacopoeia 31

•           Microbiological assay (dry basis): ≥ 40 IU/mg

•  ;         Zinc content: 2.0 - 10.0%

•           Loss on drying: ≤5.0%

Indication and Application

Ø        Treatment of local infections on skin, ear and eye

Ø        Use in topical creams, topical/ophthalmic ointments, powders and otic solutions, mainly as a combination drug

Regulatory Compliances

Ø        Following documents are available as requested

•           EU Drug Master File (DMF) with full impurity profile complies with EMA  requirements

•          ; AustraliaGMP Compliance Letter

•           Chinese MOA GMP certificate

•           Letter of Access

Availability

Non-sterile product of bacitracin zinc (Micronized or Non-micronized) complied with EP 9.0 (≥60 IU/mg), USP39 (≥65 IU/mg), and USP31(≥40 IU/mg),areavailable. Each product has different package (aluminum can) sizes of 2 kg, 5 kg, and 20 kg, respectively.

Other Information

Ø        Self-life is 36months from the date of manufacture

Ø        Protect contents from humidity after opening, store in a dry and cool place