Aspartame (N PHARMACOPOBIA 80 uROPEA st romstography aan pone substancs, Thayer hrs er tton (a). Dissolve 0.28 of the wbstance fo be eaten etanier enng ne een ge a en) Die olution (a) to 10 mb. to). Det a et Tonk erence ol Spat with » 01/20170973 Aspartamum, (a), ioe 14 mi a et saan (0) Mec an (Ds 28 m4 Ry et tet sotto (aan eeu piss 28mg of aipara My RS utr Rand dt to 10 9 wi the M2943 gluta acid Rn ite to 10s ae {-methoxy--oxo-3-phenylpropan: ae 0: yheniylalaninate). a . and Sepia) etiam 10 ype sorption: maxima: at 242 nm am, 258 nm at Wh the same acid, Shake 3 times with 10 mi of meth tabu elone R for 3 min, Wash the combined lass with 10 mL of water R for 3 min, The aq Bae tal R ‘complies with the limit test for iron, en et af a) a th C, Thin-layer chromat shy 25m of water Rand dite to le mL wil ace aed R Assay TEC gel plate Dissolve 0.110 gn § ml oF anhydrous forme acl R Add Z : Besofenndin sci widh itaemih 01M pee Mob phn: at an dow cad ment Si detersning the end-point poteniomernealy 2.20, ee ee acs » Tal of 0.1. perchloric acid is equivalent to 13.21 mg erence ase? Development: ovct a path of 18 er, IMPURITIES: ‘i Detection: spray with ninhydrin solution Rand heat a Sahn impure: A,B 100-108"C far sm vs Result: the sot in the chromatogram obtained with the spat in the chromatogram obtained wth te tele 4-(25)-2-aminobutanedicic acid (aspartic acid, solntion, ie lve aout 20 mg in Smo of meRanal Rand ad ee of elaine hydrosylomie solaton A nt aterbath for 15 min, Allow to cool and adjust to about PH2 wih dilute hycrochovic aid RLAGA 0.1 mol fore ‘orlde solution RI. 4 beownish-ted colour is prodiced, casi (glutamic ai) Goal tics (apo al monographs and oer ar 1763Aspartieacid ‘Tests, Solution S. Dissolve 08 gin carbon dioxide fre water Rand ‘te to 10 wth the same solvent ce of solution, Solution Si ler (2.2.1) and not there intensely coloated than reference soluton GY, (22.2, ‘Method I Conductivity (2.2.38): mexium 30 Sem Disgove 080g in carbon dlionte-free water R prepared fo disited water ® and alte to 100.0 mal. with the she sl ‘Measure the conductivity of the soltion (C,) ad tha of the rater weed for preparing the solution (C.). Phe readings must TReatable within 1 percent over period of 30 « ‘Calle the conductivity f the wolation ofthe substance to Ibe extn using the Fllawing expression: ‘Specific optical rotation (227): + 14.510 + 165 (dried sibsunce Disgave 200 gf « 690 g/L solution of anbysrou formic ‘cid R and ane $00 ml ith the same sohtion, Measure srthin 30 min of preparation. Related substances, Ligui sh Test solution. Dissolve 0.60 g of the substance to ina mixture of 1.5 volumes of glacial acetic ald Rand ‘e:Svolumes of water and date to 100.0 amistre of solvents. Reference solution (a) Dissolve 45 mg of asp impurily A CRS ins mixture of 13 volumes of cid Rand 985 volumes of water Rand dae to 30. mi wit the same mixture of sohents. Reference sri (0). Dissolve 30.0 m (ampurty ©) ina mictare of 13 volunes of lata acc and 85 volumes of water Rand dst to 1000 sik with the Same lature of salvents lute 10 ml ofthis solution TOO with water Seference solution), Dilute $0 ml ofthe tet slution to 100m with water R.Dilte 30 ml. of this so 1000 ea. with water Reference olson (d) Dissolve 300mg of aspartyLt phenlalarine B(mpusity 8) ina mitite of 13 volumes of flail acetic acid Band 83 volumes of mate Rand dilute 10 TOGO ml with the same mixture of sulvens, Dilute 1. mb of thesolstion 9100 ml with water 8 Mit 10 mb of this Sedation vith 0 mL-of reference salition (8). Column ~ #22:1= 025m, 0-40 mm. ~ stationary phase: octad Shromatgraphy RS 10 tm) Mobil pase mia 0 volumes of aetntrie Rand 90 volumes £3684 solution of potassium dyrhogen phosphors Previn adused to pf147 wih phophoneend en © Flow rate: min Detstion: pectophooneer 20 Injection: 2. 4 ine. wie the retestion tine of asparame Sper sabi: lee scation (8). ~ resolution: ninizaum 3.5 between the pea ‘pion: minimum 3 between he peaks do Limits: ~ impurity A: not more than the area of the pri ipa Asn mor of the principal peak {athe chumatoram obtained wih sefrtee ation (0) ~ impuriy C904 nexe than the aro tn pi snp pina peak igh comaiogran cine wih ede late) RoPEAN PHARMACOPOEIA 12 sna and Cent ore a the her ae chromate? fis per cen rk due tO the solvent regard Timi: asregae a8) PE eye i, determined on oases Loon dying (2232): set by inein avo Sana ah (24): asi She drous jormic acid Rand Dissolve 0.250 g in 1.5 mL-of any pa eR Titrate immediately 0 mi of any rat end-point fen 13 perch cd determi iometrially (2220) cui mL of 04 M gerd STORAGE IMPURITIES Ohler detcude panies ie flowing substances would, nese slfient eel be detected by one or other of the tests inthe mon They ae limited by the ge 2 (adbd) hls nero not necessary to Kintify the i. l . toiabeenney ese ae © 25)2:smino-5-phenylpropanoic Ee ‘cid (phenylalanine). o1/2017.0797 ASPARTIC ACID Acidum asparticum a pes artic AP nore 152 oo (cHARAGI pte oF Atal ai Sonali tt Solutions 0 IDENTIFI part identi second ier A. Specific A suspe ab . xamine (2220), expert ae . Examine anhydri Appearance a and dil lear (22.1) solution BY, Specific opti eto examined in water R. with water R Reference so 2 mL of dil Reference 20 mi with Refer and Tome of and dilutes