Edition: BP 2025 (Ph. Eur. 11.6 update)
DEFINITION
Talc Dusting Powder is a sterile cutaneous powder of suitable fineness consisting of 10% of starch1 and 90% of Purified Talc.
PRODUCTION
The starch is triturated with the Purified Talc and passed through a sieve of suitable mesh size (250 µm may be suitable). Either the Purified Talc is sterilised before use or the final product is subjected to a suitable sterilisation procedure.
The dusting powder complies with the requirements stated under Topical Powders and with the following requirement.
Acid-insoluble matter
86.0 to 91.0% when determined by the following method. Boil 0.5 g with 10 mL of 2M hydrochloric acid for 5 minutes, cool, filter through a tared sintered-glass crucible (ISO 4793, porosity grade 4, is suitable), wash the residue with water until the washings are free from acid and dry to constant weight at 105°.
1 Maize Starch, Potato Starch, Rice Starch, Wheat Starch or, in tropical and subtropical countries where these are not available, Tapioca Starch may be used.
