Patent ID: 8354428

Claim:
Laquinimod sodium as being greater than 98% pure: a) in a crystalline Form A1; b) in a crystalline Form A3; or c) in a crystalline Form A4; wherein: e) the crystalline Form A1 has one or more of the following properties: i) a powder X-ray diffraction pattern substantially in accordance with FIG. 4 ; ii) a powder X-ray diffraction pattern having peaks at about 9.1, 10.7 and 11.2±0.2 degrees 2-theta; iii) a powder X-ray diffraction pattern having additional peaks at about 7.25, 9.72, 10.03, 13.08, 13.91, 14.57, 14.99, 15.69, 16.12, 16.75, 17.57, 18.15, 19.16, 19.87, 20.44, 21.24, 21.68, 21.88, 22.98, 23.79, 24.63 and 25.63±0.2 degrees 2-theta; iv) an IR spectrum substantially in accordance with FIG. 5 ; v) an IR spectrum having absorption bands at about 3377, 3062, 2972, 2933, 1611, 1585, 1528, 1495, 1414, 1377, 1347, 1325, 1255, 1220, 1178, 1098, 811 and 697±2 cm −1 ; and vi) a DSC thermogram substantially in accordance with FIG. 6 ; f) the crystalline Form A3 has one or more of the following properties: i) a powder X-ray diffraction pattern substantially in accordance with FIG. 10 ; ii) a powder X-ray diffraction pattern having peaks at about 6.44, 6.65, 7.72 and 8.77±0.2 degrees 2-theta; iii) a powder X-ray diffraction pattern having additional peaks at about 9.31, 9.60, 10.71, 11.14, 11.66, 13.25, 14.61, 15.32, 17.62, 17.98, 18.54, 19.21, 21.38, 22.11, 22.59, 23.43, 23.99, 25.04, 25.44 and 27.86±0.2 degrees 2-theta; iv) an IR spectrum substantially in accordance with FIG. 11 ; v) an IR spectrum having absorption bands at about 3368, 2970, 2936, 1615, 1583, 1526, 1495, 1412, 1377, 1344, 1326, 1253, 1218, 1177, 1097, 813 and 699±2 cm −1 ; and vi) a DSC thermogram substantially in accordance with FIG. 12 ; g) the crystalline Form A4 has one or more of the following properties: i) a powder X-ray diffraction pattern substantially in accordance with FIG. 13 ; ii) a powder X-ray diffraction pattern having peaks at about 6.09, 7.46 and 10.42±0.2 degrees 2-theta; iii) a powder X-ray diffraction pattern having additional peaks at about 7.82, 8.47, 10.12, 14.15, 16.10, 18.95, 22.66, 23.50, 25.84, 26.13, 28.24, 29.07, 29.81, 31.62 and 33.94±0.2 degrees 2-theta; iv) an IR spectrum substantially in accordance with FIG. 14 ; v) an IR spectrum having absorption bands at about 3413, 2974, 2935, 1612, 1584, 1524, 1495, 1413, 1377, 1346, 1327, 1253, 1219, 1177, 1097, 811 and 698±2 cm −1 ; and vi) a DSC thermogram substantially in accordance with FIG. 15 .