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Aqueous Enteric Coating Polymer

Aqueous Enteric Coat L30D is an aqueous dispersion of a neutral co-polymer which confirms to USP/NF specifications of “Methacrylic Acid Co-Polymer”, Type C.

Aqueous Enteric Coat L100D is spray dried powder of Aqueous Enteric Coat L30D dispersion. It is an anionic polymer which confirms to USP/NF specification of “Methacrylic Acid Co-Polymer”, Type C.
Enteric coating of tablets, pills, pellets, granules, and powders.
Appearance : Aqueous Enteric Coat L30D forms colourless and transparent film in presence of plasticizers, colour can be given with pigments.
Solubility : The Aqueous Enteric Coat L30D films formed are insoluble in pure water, in buffer solutions below pH 5.5 and natural gastric juices. Aqueous Enteric Coat L30D films are soluble in neutral to weakly alkaline region of the digestive tract, in intestinal fluids and buffer solutions above pH 5.5
Aqueous Enteric Coat L30D Aqueous Enteric Coat L100D
Aqueous Enteric Coat L30D is a high molecular weight polymer. It is not absorbed by body tissues and is totally safe for human oral consumption. Test for toxicological tolerance show that it does not have pronounced physiological action and is non-toxic.
Solvent Enteric L100 solvent system can be adopted.
Aqueous Enteric Coat L30D film is brittle in nature. To improve film elasticity use of plasticizer is strongly recommended. The recommended plasticizers are polyethylene glycol, triacetin, triethyl citrate etc… usually 10% of plasticizer is sufficient, but if necessary, can be increased to 25%
Average Requirement
Aqueous Enteric Coat L30D : 135 gms. Enteric L30D per 1 kg. tablets for enteric coating.
Aqueous Enteric Coat L100D : 40 gms. Enteric L100D per 1 kg. tablets for enteric coating.
At low temperature below 400c and keep away from frost.
Shelf Life
Two years for Aqueous Enteric Coat L30D & five years for Aqueous Enteric Coat L100D from the date of manufacturing. Keep the container in tightly closed condition.
Aqueous Enteric Coat L30D : 5 kg, 20 kg, net in H.D.P.E. drum.
Aqueous Enteric Coat L100D : 5 kg, 20 kg, in corrugated box.
Certificate of Analysis
Test Specification Results
Description Milky White Liquid of Low Viscosity Milky White Liquid Of Low Viscosity
Solubility Soluble in Acetone Alcohol, IPA Soluble In I.P.A. & Acetone
Identification A. Complies
B. Complies
Viscosity Dry Polymers BET’N 100 TO 200 120 Cps
pH BET’N 2.0 TO 3.0 2.71
Acid Value (mgKOH/gms dry substance) BET’N 300 TO 330 310
Residue on Ignition NMT 0.2% Conforms
Heavy Metals NMT 0.002% Conforms
Limit of monomers NMT 0.01% 0.00246%
Coagulum Content The Weight Of The Residue Does Not Exceed 1000 Mg. (1%) Conforms
Assay for Methacrylic Acid Copolymers Content Bet'n 46.0 To 50.6% 47.74%
Emulsion%Solid 28.50 To 31.50% 30.8%
Emulsion Viscosity Nmt 15 Cps 06 Cps