Ethanol → Clindamycin

Participants

Reaction Steps

Manufacture Complex a) Mix ethanol and purified water using a homogeniser. b) With continuous homogenisation, add the clindamycin phosphate (weight corrected for assay and water content) to form a suspension. c) While mixing continues, slowly add sodium hydroxide 30% w/w to a pH of 7.5 (allowing clindamycin phosphate to dissolve). Record pH and calculate total amount of water added. d) Dissolve zinc acetate dihydrate in purified water and mix until a clear solution is formed. e) With continuous homogenisation add the zinc acetate solution to the pH 7.5, clindamycin phosphate solution. Continue mixing, until a homogeneous, translucent, white gel forms. This process may take place as a number of smaller sub-batches. Cellulose Gel Base f) Mix propylene glycol and ethanol 96% until homogeneous. g) While homogenising, add hydroxyethylcellulose until a clear, homogeneous, gel is formed. Final Gel Manufacture h) Add the clindamycin phosphate zinc complex to the base gel and mix until a uniform, white opaque gel is produced. i) Add water to 100% and mix to homogeneity. j) Fill into tubes.

Provenance & Evidence