What Is Bacitracin?

Introductions

Bacitracin Structure
Bacitracin Chemical Structure

Bacitracin is a white to off-white powder soluble in water and ethanol.

First isolated in 1945 from soil bacteria of the group Bacillus subtilis, and later commercially produced, bacitracin is a mixture of related polypeptides widely used as an antibiotic in injections or topical formulations.

It is a mixture of related compounds with different antibacterial activities.

Bacitracin is an effective narrow-spectrum polypeptide with an antibacterial spectrum similar to penicillin and effective against Gram-positive bacteria.

These polypeptides inhibit Gram-positive bacteria by interfering with the cell wall and peptidoglycan synthesis.

Its related components include compounds A, A1, B, B1, B2, C, D, E, F, G, and X.

Of all those 11 components, compound A was found to have the most antibacterial activity. Compounds B1 and B2 have similar efficacies and are approximately 90% as active as compound A.

The rest of the components do not appear to be extensively studied.

What Are Bacitracin Related Ingredients?

As per Monographs in USP38-NF33 S2, it has 8 related ingredients:

A, B1, B2, B3, C1, C2, C3, and F, are the impurities listed in USP.

But according to Wikipedia, it is made up of 11 components: A, A1, B, B1, B2, C, D, E, F, G, and X.

Bacitracin related ingredients

Among the 8 substances, 4 of them are active ingredients: A, B1, B2, and B3.

The rest of the ingredients are regarded as impurities such as Bacitracin C1, C2, C3, and F.

How Is Bacitracin API Produced?

It is commercially manufactured by growing the bacteria Bacillus subtilis var Tracy I in a container of liquid growth medium.

After a certain period, the bacteria synthesize the antibiotic and secrete the antibiotic into the medium.

Then the antibiotic is extracted from the medium through chemical processes.

1. Fermentation:

Use Bacillus subtilis and B. licheniformis to get its solution.

The solution is an extraction and separation solution of a Bacillus subtilis and a B-type Bacillus licheniformis fermentation broth with a potency of no less than 5000 u/ml and conductance of less than 2000 μs/cm.

2. Adjusting PH value:

An alkaline solution is added to its solution to adjust the pH from 8 to 11.

Adjust pH from 5 to 7 with an inorganic acid.

Stir it for 1 to 2 hours, and let it stand for 5 to 10 hours.

3. Extraction and Purification:

it is then obtained by membrane separation, drying, pulverization, and sieving.

The spray-dried powder obtained by the processing above can be used as pharmaceutical raw materials for medicinal preparations such as injections and ointments with polymyxin b sulfate.

USP requires that the total content of compound A is no less than 40.0%.

The total amount of A, B1. B2 and B3 should be greater than 70.0% and the potency is no less than 60IU/MG.

What Is The HS Code Of Bacitracin? (2023.08.10 updated)

If you plan to import Bacitracin API or formulations from China, please check it is HS Code as below:

Chemically speaking, bacitracin belongs to the class of organic compounds known as polypeptides. 

These are peptides containing ten or more amino acid residues.

But still, it is an antibiotic, and it is classified as other antibiotics with HS Code 2941909099 (其它抗生素) in Chinese Customs.

If you are importing its finished dosages such as injections, the related HS Code should be 3004909099 (Other medicines with prescribed doses-其他已配定剂量的药品).

How To Ship and Store Bacitracin?

#1. Shipment

First of all, it is a very safe chemical to be shipped by air.

It has been tested by DGM and regarded as a common and safe chemical since 2008 or earlier.

And it is suitable for shipment by air, by express and by sea packed in normal packing materials

Certificate of safe air transportation issued by DGM has shown that bacitracin is non-flammable, not dangerous, not poisonous, etc.

As to how you want to ship the pure powder, it all depends on its quality standards.

If you are importing injection-grade bacitracin, you may want it to be shipped as fast as you can at a low temperature.

Shipping by air or by express is your best option, to rule out any possible high temperatures.

Because the injection-grade powder is more expensive than topical-grade types, you have good reasons to spend extra bucks on the shipping.

If you are procuring some bulk powder for research such as bacterial growth, you may ship it by express/courier, with or without ice pads as you like.

Though normal-temperature shipment will not affect its activity too much, it is better you ship it at a low temperature to make sure its potency.

#2. Storage

The bulk bacitracin powder is relatively stable during room-temperature storage.

Our stability tests have shown that it is stable for at least 36 months when it is stored in a dry environment and protected from the sunlight at room temperature.

So you can store the powder according to the conditions above if you are storing it for topical formulations.

For storage of injection-grade powder, low-temperature storage conditions (2~8 Degrees Celsius or lower) are recommended.

References

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