Change to read:
Labeling—
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.
NF24
Viscosity—
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; and
rU and
rS are the benzene peak responses obtained from the
Test solution and the
Standard solution, respectively: not more than 0.2% is found.
for 1 hour, contains not less than 52.0 percent and not more than 62.0 percent of carboxylic acid (–COOH) groups. The viscosity of a neutralized 1.0 percent aqueous dispersion of Carbomer 1342 is between 9500 and 26,500 centipoises.
467
:
meets the requirements.