Pharmaceutical Ingredients

Regulatory

Product Regulatory Information — US FDA Inactive Ingredients Status

  Toxicology Data Developed by Lubrizol Advanced Materials
Product Residual Solvent Listing in U.S. FDA's Database of Inactive Ingredients Acute Subacute/Subchronic Chronic
Carbopol® Polymers
71G NF Ethyl acetate Carbomer 941 R
(Carbopol 974P NF)
R
(Carbopol 974P NF)
 
971P NF Ethyl acetate Carbomer 941 R
(Carbopol 974P NF)
R
(Carbopol 974P NF)
 
974P NF Ethyl acetate Carbomer 934P
and Carbomer 974P
 
980 NF Cosolvent Carbomer 940
and Carbomer 980
   
981 NF Cosolvent Carbomer 941
and Carbomer 981
R
(Carbopol 980 NF)
   
5984 EP Cosolvent Carbomer 934 R
(Carbopol 934 NF)
R
(Carbopol 934 NF)
R
(Carbopol 934 NF)
Ultrez 10 NF Cosolvent      
Carbopol® Polymers
934 NF Benzene Carbomer 934
934P NF Benzene Carbomer 934P
940 NF Benzene Carbomer 940    
941 NF Benzene Carbomer 941    
1342 NF Benzene Carbomer 1342    
Pemulen Polymers
TR-1 NF Cosolvent Carbomer 1342    
TR-2 NF Cosolvent Carbomer 1342 R
(Pemulen TR-1 NF)
   
Noveon® Polycarbophils
AA-1 USP Ethyl acetate Polycarbophil      
CA-1 USP Water Polycarbophil, Calcium      
CA-2 USP Water Polycarbophil, Calcium      

• - Indicates toxicity data has been developed on the polymer
R - Indicates read across data has been used to characterize the toxicity of the polymer. The source of the read across is shown in parenthesis

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