Name: Bacitracin Zinc

roduct 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

FAQ

Q1:Why do you choose Greenbo Biochem as your partner?

A1.High quality can be guaranteed. Greenbo Biochem since 1990 are reputed API manufacturer and are Certified by ISO,GMP,FDA and have CEP/COS certification.Free sample can be arranged before shipment and SGS,BV and other third party inspection company are accepted before loading.For regular customers, we accept L/C payment term. If there is any quality problem after goods arrive. Greenbo Biochem will do fully payment refund. 

A2. Best price can be guaranteed. As Greenbo Biochem are integrated pharmaceuticals and chemicals producer

the production cost can be controlled and price will be definitely more competitive than China trading companies.

A3.Professional engineer from Greenbo Biochem will give professional usage guide and services after sales.

Q2: Can i get some samples?
A: Yes, we can supply the free sample, but the shipping cost be paid by our customers.
Q3: How to start orders or make payments?
A: Proforma invoice will be sent first after confirmation of order, enclosed our bank information. Payment by T/T, Western Union or Paypal or Escrow(Alibaba).
Q4: How to confirm the Product Quality before placing orders?
A:You can get free samples for some products,you only need to pay the shipping cost or arrange a courier to us and take the samples. You can send us your product specifications and requests,we will manufacture the products according to your requests.
Q5:What’s your MOQ?
A:Our MOQ is 1kg. But usually we accept less quantity such as 100g on the condition that sample charge is 100% paid.
Q6: How about delivery lead time?
A:Delivery lead time: About 3-5 days after payment confirmed. (Chinese holiday not included)