Manufactured according to Good Manufacturing Practice(GMP) CAS No.: 1405-89-6 Molecular Formula: [C66H103N17O16S].nZn
Bacitracin Zinc(USP/CP/EP)
Definition:Bacitracin Zinc is the zinc complex of bacitracin, which consists of a mixture of antimicrobial polypeptides produced by certain strains of bacillus licheniformis and by bacillus subtilis var. tracy and which on hydrolysis yields the amind acids L-cysteine, D-glutamic acid, L-histidine, L-lsoleucine, L-leucine, L-lysine, D-ornithine, D-phenylalenine and DL-aspartic acid.
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 | |
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 inalcohol | Slightly soluble in water and inalcohol |
Zinc Content | 2.0 per cent to 10.0 per cent, calculated with reference tothe dried substance. | 4.0 per cent to 6.0 per cent, calculated with reference tothe dried substance. |
Composition | \ | Bacitracin A is more than 40 per cent,Sum of Bacitracin A, B1 B2 and B3 ismore 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 tothe dried substance. | Not less than 60IU per mg,calculated with reference tothe dried substance. |
STORAGE:Store in an airtight container, store in a cool dry place.
Package: 1kg/5kg/20kg per drum or aluminum.
Shelf Life:Three years stored below 25°C in manufacturer’s original packaging material
Bacitracin Zinc
