Pharmaceutical Ingredients

Regulatory

Product Regulatory Information — Global Regulatory Status of Lubrizol's Polymers

		Pharmacopoeia Monograph Compendial Name			Drug Master File Number
Product Trade Name	Residual Solvent	United States (USP/NF)	Europe (Ph. Eur.)	Japan¹ (JPE)	U.S.	Europe
Carbopol^® Polymers
71G NF	Ethyl acetate	Carbomer Homopolymer Type A Previous USP/NF Name: Carbomer 941	Carbomers	Carboxyvinyl Polymer	17095 26860
971P NF	Ethyl acetate	Carbomer Homopolymer Type A Previous USP/NF Name: Carbomer 941	Carbomers	Carboxyvinyl Polymer	7170 26860
974P NF	Ethyl acetate	Carbomer Homopolymer Type B Previous USP/NF Name: Carbomer 934P	Carbomers	Carboxyvinyl Polymer	7170 26860	Yes
980 NF	Cosolvent²	Carbomer Homopolymer Type C Previous USP/NF Name: Carbomer 940	Carbomers	Carboxyvinyl Polymer	10072	Yes
981 NF	Cosolvent²	Carbomer Homopolymer Type A Previous USP/NF Name: Carbomer 941	Carbomers	Carboxyvinyl Polymer	10071
5984 EP	Cosolvent²	Carbomer Homopolymer Type B Previous USP/NF Name: Carbomer 934	Carbomers	Carboxyvinyl Polymer	13855
Carbopol^® Polymers
934 NF	Benzene	Carbomer 934		Carboxyvinyl Polymer	153
934P NF	Benzene	Carbomer 934P		Carboxyvinyl Polymer	153
940 NF	Benzene	Carbomer 940		Carboxyvinyl Polymer	153
941 NF	Benzene	Carbomer 941		Carboxyvinyl Polymer	153
1342 NF	Benzene	Carbomer 1342			7757
Pemulen™ Polymers
TR-1 NF	Cosolvent²	Carbomer Copolymer Type B			7757
TR-2 NF	Cosolvent²	Carbomer Copolymer Type A			7757	Yes
Carbopol^® Polymers
ETD 2020 NF	Cosolvent²	Carbomer Interpolymer Type B			12924
Ultrez 10 NF	Cosolvent²	Carbomer Interpolymer Type A			12954
Noveon^® Polycarbophils
AA-1 USP	Ethyl acetate	Polycarbophil			7618

¹ Based on customer request, Lubrizol certifies select lots of product against the JPE Carboxyvinyl Polymer Monograph.
² Cosolvent system made using cyclohexane and ethyl acetate