Change to read:
Label it to indicate that it is not intended for internal use.
A carbomer copolymer manufactured using benzene and complying with the unique requirements of this monograph will be officially titled Carbomer 1342 and will not be referred to as Carbomer Copolymer
Proceed as directed in the test for Viscosity
under Carbomer 934P,
except to perform the test on a 1.0% aqueous dispersion (prepared by using 5.00 g instead of 2.50 g) and omit the 30-minute incubation of the solution before the titration. The viscosity is between 9500 and 26,500 centipoises.
Limit of benzene
Proceed as directed in the test for Limit of benzene
under Carbomer 934P
, except to use about 50 mg of Carbomer 1342, accurately weighed, instead of about 1 g of Carbomer 934P, to prepare the Test solution.
Calculate the percentage of benzene in the portion of Carbomer 1342 taken by the formula:
10(C/W)(rU / rS)
in which C
is the concentration, in µg per mL, of benzene in the Standard solution; W
is the weight, in mg, of Carbomer 1342 taken to prepare the Test solution;
are the benzene peak responses obtained from the Test solution
and the Standard solution
, respectively: not more than 0.2% is found.