METHACRYLIC ACID - METHYL METHACRYLATE …

1 EUROPEAN PHARMACOPOEIA acid - METHYL METHACRYLATE copolymer (1:1)Particulate matter. Filter g through a tared stainlesssteel sieve (90). Rinse withwater Runtil a clear filtrate isobtained and dry at 100-105 C. The residue weighs notmore than acrylate and METHACRYLIC ( ).Blank ml ofmethanol Radd ml solution. Dissolve 40 mg of the dispersion to beexamined in ml ofmethanol Rand add ml of themobile solution. Dissolve 10 mg ofethyl acrylate Rand10 mg ofmethacrylic acid Rinmethanol R, ml with the same solvent. Dilute ml of this solutionto ml withmethanol Rand add ml of the : size:l= , =4mm; stationary phase:octadecylsilyl silica gel forchromatography R(5 m).Mobile phase:methanol R,phosphate buffer solutionpH R(30:70V/V).

2 Flow : spectrophotometer at 202 :50 suitability: resolution: minimum between the peaks due toethyl acrylate and METHACRYLIC acid in the chromatogramobtained with the reference solution; the chromatogram obtained with the blank solution doesnot show peaks with the same retention times as ethylacrylate or METHACRYLIC : sum of the contents of ethyl acrylate and on evaporation: per cent to per g at 110 C for 5 h. The residue weighs not lessthan g and not more than ash( ): maximum per cent, determinedon contamination. Total viable aerobic count ( )not more than 103micro-organisms per gram, determinedby plate Rand 60 mlof2-propanol R. Titrate slowly while stirring Msodium hydroxide,usingphenolphthalein solution M sodium hydroxideis equivalent to mgof C4H6O2( METHACRYLIC acid units).

3 STORAGEP rotected from freezing. Handle the substance so as tominimise microbial label states, where applicable, the name andconcentration of any surface-active :1127corrected acid - METHYLMETHACRYLATE copolymer (1:1)Acidi methacrylici et methylis methacrylatispolymerisatum 1:1 DEFINITIONC opolymer of METHACRYLIC acid and METHYL methacrylatehaving a mean relative molecular mass of about 135 ratio of carboxylic groups to ester groups is about 1 : per cent to per cent of methacrylicacid units (dried substance).CHARACTERSA ppearance: white or almost white, free-flowing : practically insoluble in water, freely soluble inanhydrous ethanol and in 2-propanol, practically insolublein ethyl acetate. It is freely soluble in a 40 g/l solution ofsodium Infrared absorption spectrophotometry ( ).

4 Comparison:Ph. Eur. reference spectrum ofmethacrylic acid - METHYL METHACRYLATE copolymer (1:1).B. It complies with the limits of the viscosity( ): 50 mPa s to 200 mPa a quantity of the substance to be examinedcorresponding to g of the dried substance in a mixtureof g ofwater Rand g of2-propanol R. Determinethe viscosity using a rotating viscometer at 20 C and at ashear rate of 10 s of a film. Place 1 ml of the solution prepared inthe test for apparent viscosity on a glass plate and allow todry. A clear brittle film is METHACRYLATE and METHACRYLIC ( ).Blank ml ofmethanol Radd ml ofthe mobile solution. Dissolve 40 mg of the substance to beexamined in ml ofmethanol Rand add ml of themobile solution.

5 Dissolve 10 mg ofmethyl METHACRYLATE Rand 10 mg ofmethacrylic acid Rinmethanol R, to ml withmethanol Rand add ml of themobile : size:l= , =4mm; stationary phase:octadecylsilyl silica gel forchromatography R(5 m).Mobile phase:methanol R,phosphate buffer solutionpH R(30:70V/V).Flow : spectrophotometer at 202 :50 (1)applytoallmonographsandothertexts2373 METHACRYLIC acid - METHYL METHACRYLATE copolymer (1:2)EUROPEAN PHARMACOPOEIA suitability: resolution: minimum between the peaks dueto METHYL METHACRYLATE and METHACRYLIC acid in thechromatogram obtained with the reference solution; the chromatogram obtained with the blank solution doesnot show peaks with the same retention times as methylmethacrylate or METHACRYLIC : sum of the contents of METHYL METHACRYLATE andmethacrylic on drying( ): maximum per cent, ash( ): maximum per cent, determinedon Rand 60 mlof2-propanol R.

6 Titrate slowly while stirring Msodium hydroxide,usingphenolphthalein solution M sodium hydroxideis equivalent to mgof C4H6O2( METHACRYLIC acid units).01/2008:1130corrected acid - METHYLMETHACRYLATE copolymer (1:2)Acidi methacrylici et methylis methacrylatispolymerisatum 1:2 DEFINITIONC opolymer of METHACRYLIC acid and METHYL methacrylatehaving a mean relative molecular mass of about 135 ratio of carboxylic groups to ester groups is about 1 : per cent to per cent of methacrylicacid units (dried substance).CHARACTERSA ppearance: white or almost white, free-flowing : practically insoluble in water, freely soluble inanhydrous ethanol and in 2-propanol, practically insolublein ethyl acetate. It is freely soluble in a 40 g/l solution ofsodium Infrared absorption spectrophotometry ( ).

7 Comparison:Ph. Eur. reference spectrum ofmethacrylic acid - METHYL METHACRYLATE copolymer (1:2).B. It complies with the limits of the viscosity( ): 50 mPa s to 200 mPa a quantity of the substance to be examinedcorresponding to g of the dried substance in a mixtureof g ofwater Rand g of2-propanol R. Determinethe viscosity using a rotating viscometer at 20 C and at ashear rate of 10 s of a film. Place 1 ml of the solution preparedfor the viscosity test on a glass plate and allow to dry. A clearbrittle film is METHACRYLATE and METHACRYLIC ( ).Blank ml ofmethanol Radd ml ofthe mobile solution. Dissolve 40 mg of the substance to beexamined in ml ofmethanol Rand add ml of themobile solution. Dissolve 10 mg ofmethyl METHACRYLATE Rand 10 mg ofmethacrylic acid Rinmethanol R, to ml withmethanol Rand add ml of themobile : size:l= , =4mm; stationary phase:octadecylsilyl silica gel forchromatography R(5 m).

8 Mobile phase:methanol R,phosphate buffer solutionpH R(30:70V/V).Flow : spectrophotometer at 202 :50 suitability: resolution: minimum between the peaks dueto METHYL METHACRYLATE and METHACRYLIC acid in thechromatogram obtained with the reference solution; the chromatogram obtained with the blank solution doesnot show peaks with the same retention times as methylmethacrylate or METHACRYLIC : sum of the contents of METHYL METHACRYLATE andmethacrylic on drying( ): maximum per cent, ash( ): maximum per cent, determinedon g in a mixture of 40 ml ofwater Rand 60 mlof2-propanol R. Titrate slowly while stirring Msodium hydroxide,usingphenolphthalein solution M sodium hydroxideis equivalent to mgof C4H6O2( METHACRYLIC acid units).

9 01/2008:0408corrected HYDROCHLORIDEM ethadoni [1095-90-5]2374 See the information section on general monographs (cover pages)