Carbomer 1342
»Carbomer 1342is a high molecular weight copolymer of acrylic acid and a long chain alkyl methacrylate cross-linked with allyl ethers of pentaerythritol.Carbomer 1342,previously dried in vacuum at 80for 1hour,contains not less than 52.0percent and not more than 62.0percent of carboxylic acid (–COOH)groups.The viscosity of a neutralized 1.0percent aqueous dispersion of Carbomer 1342is between 9500and 26,500centipoises.
Packaging and storage— Preserve in tight containers.
Labeling— Label it to indicate that it is not intended for internal use.
Viscosity— Proceed as directed in the test for Viscosity underCarbomer 934Pexcept to perform the test on a 1.0%aqueous dispersion (prepared by using 5.00g instead of 2.50g)and omit the 30-minute incubation of the solution before the titration.The viscosity is between 9500and 26,500centipoises.
Limit of benzene— Proceed as directed in the test for Limit of benzene underCarbomer 934P,except to use about 50mg of Carbomer 1342,accurately weighed,instead of about 1g of Carbomer 934P,to prepare the Test solution.Calculate the percentage of benzene in the portion of Carbomer 1342taken by the formula:
10(C/W)(rU/rS),
in which Cis the concentration,in µg per mL,of benzene in the Standard solution;Wis the weight,in mg,of Carbomer 1342taken to prepare the Test solution;and rUand rSare the benzene peak responses obtained from the Test solutionand the Standard solution,respectively:not more than 0.2%is found.
Other requirements— It meets the requirements for Identification,Loss on drying,Heavy metals,andAssay for carboxylic acid content underCarbomer 934P.
Auxiliary Information— Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2974
Phone Number:1-301-816-8262