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Bacitracin Zinc

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Detailed Product Description

It is applied topically in the treatment of local infections, mainly infections of the skin, ear and eye. It is often formulated in combination with other active ingredients in topical creams, powders and solutions, topical and ophthalmic ointments, and otic solutions.
Appearance
A white of light-yellowish-grey powder, hygroscopic, slightly soluble in water and in alcohol, very slightly soluble in either.

CAS No.
1405-89-6

Molecular Formula
[C₆₆H₁₀₃N₁₇O₁₆S]·nZn

Regulatory status
→ Manufactured according to Good Manufacturing Practice(GMP)
→ DMF for non-sterile grades available on request.
→ COS for non-sterile is under preparation.

TEST

Analysis Item	Quality Standard
Analysis Item	USP (Min.40IU/mg Min.60IU/mg)	EP (Min.60IU/mg)
pH	6.0 - 7.5	6.0 - 7.5
Loss on drying	Not more than 5.0 per cent.	Not more than 5.0 per cent.
Solubility	Slightly soluble in water and in alcohol	Slightly soluble in water and in alcohol
Zinc Content	2.0 per cent to 10.0 per cent, calculated with reference to the dried substance.	4.0 per cent to 6.0 per cent, calculated with reference to the dried substance.
Composition	\	Bacitracin A is more than 40 per cent, Sum of Bacitracin A, B1 B2 and B3 is more than 70 per cent
Related peptides	\	Not more than 20 per cent
Impurity E	\	Not more than 6 per cent
Assay	Not less than 40IU per mg, calculated with reference to the dried substance.	Not less than 60IU per mg, calculated with reference to the dried substance.