%PDF-1.5 %���� For testing solubility in medium, the starting concentration is 20,000 mg/ml (i.e., 20 mg/mL) in Tier 1, but for DMSO and ethanol the starting concentration is 200,000 mg/ml (i.e., 200 mg/mL) in Tier 2. The chapter also briefly describes typical experimental methods used to assess solubility determination of pharmaceutical materials. (�,Ir�:M�7tz��+�!��XD��k��Q,�*KNJu�V������������)��Ws/dJ�P��,(:/��Y�r��o�K5E49��"���&8 �Xb��y�7�j����&���j����W�>m�pt�8�x�Z췫�N�&��]��Ȧb��r'�xiX#�������i"���B�^Pq� �?��*@,����Aɤ�d4��)��L� *�ڙ�!�LJPq�� L��L ��d��R�"8�. endstream endobj startxref x�b```�l����cb��@ޑ6e ��� S}]�Z�-�Z@�yT�L�3ҙ�^�v�03�yp�q�b� Z�Na;0Wt4�vt04�D I0b��`�`�h�0d�� �T,���ړ_p�����w�y�,��hH���e`dNx�����[���'�S��f`�s� 3� endstream endobj 235 0 obj <>/Metadata 25 0 R/Pages 232 0 R/PageLayout/OneColumn/StructTreeRoot 45 0 R/Type/Catalog>> endobj 236 0 obj <>/ColorSpace<>/Font<>/ExtGState<>>>/Type/Page>> endobj 237 0 obj <>stream 3119 0 obj <>stream Background and objectives: The solubility of one substance in another is a measure of the degree of molecular mixing between the two pure substances at thermodynamic equilibrium. z.,�� ���c��$����?��hZ��P�����S\�W��vizqø�{Y}l���nU�h��}�F��K����=|T˧�!��Bq!����Ɇ��G'�m����. ���9S��X+�N�"�Vހ��1F��c��5zY�$�1�^ZϜ�Ԡ�8sFivQ�Ͳ1�=��r�T��ի�k����՛��;m�m5O��i������}8;R�Y�h����t��62���뛎iΓ�zɔ����U;�؞�ο]��MLrΙ��]Va$���o��xr���g�>� ^V���]X�ZU�u�}5��m�W]�o���:����`v=i������Á��_�:7HF�[��7 ���Y^8��" E)ȱg2���7� �P��@l�J���%8��#�h�Y-@MB� �B D-�(��s��:J���c�a�����h� h��t�z��=��G�m�w��� �u�SC>%�� ��s�� ޛ8`w�w��#��N;�����5%:��bJMX A drug substance should be classified as highly soluble when the highest dose strength is soluble in ≤250 mL of aqueous media over the pH range of 1–7.5 (5). ���{Vn ��5�iH m���~�>��C�1�ϩ>�x�������B���gZ�D)� |h��x8'„�kBx(����Г����R�9,W�e#K>�]�^1�ϟ^>�e�L� ��4�M��� o⑲v�������!�����Wj� Freely soluble in water; slightlycohol; practically insoluble in chloroform and in ether. %%EOF DJ��m� "U��$c�$;Z�n��ցMK����H��� 2[�2 ,+��=H�������� �ІaE�g��{ � &�� ea�hq``H���qf~��#T���c�V֢(G�w�.� {�fF�]�ʇ0 A drug substance is classified as highly soluble when the highest dose strength is soluble in 250 mL or less of aqueous media over the pH range of … 3082 0 obj <>/Filter/FlateDecode/ID[<6D5DE98C958B164A9A79B0061C870729>]/Index[3045 75]/Info 3044 0 R/Length 159/Prev 661891/Root 3046 0 R/Size 3120/Type/XRef/W[1 3 1]>>stream x��Y�n7�>&(��\ 0`˹�� V��6����!m���;3��ZK��M�0�h�!��ó�]i�L�D �a�Cc��ZDŽV�홰 One of the workshop outcomes was a decision by participants that the content of the new general chapter would focus on species-appropriate descriptions of conditions for testing in vitro drug USP and BP solubility criteria. From 10 to 30. 0 The information is provided for those who use, prepare, and dispense drugs, solely to indicate descriptive and solubility properties of an article complying with monograph standards. h�b```��l�>B �� For the determination of apparent s… 3045 0 obj <> endobj Descriptive term. Less than 1. The composition of a saturated solution, expressed as a proportion of a designated solute in a designated solvent, represents this thermodynamic limit of solubility. This chapter provides an overview of the concepts and equations that are relevant to solubility measurements. uY,�vdE���m�A�Q�h���8�s�XmT���"�ŬDG��(�6ZJ�l�m��~�}~Lh>� �ko�'8���*��u5.+�L��M�8^D������|4�]u�f�q��9'�Q�[��ۃŸ�|�ʂe�)X�£M�emɲ�dYZ��V'l�V#�'�V��[�:��oI Q��6�jQ@��:sSV��%y��F��h�$����G'��F������:ސd/o�k��h��p�1�H����'Jb���#��R:�=*$�(}M�7͓�t̀��?��B����� ����_�6��S�+Nw 234 0 obj <> endobj 252 0 obj <<6CF34524EBAD4E01AEAA98CA12E8A4AB>]/Info 233 0 R/Filter/FlateDecode/W[1 2 1]/Index[234 38]/DecodeParms<>/Size 272/Prev 69030/Type/XRef>>stream Very soluble. From 1 to 10. For the determination of equilibrium solubility the chapter describes the Saturation Shake-Flask Method. Soluble. Soluble in solutions of potassium and Alanine: White, odorless crystals or crystalline powder, sodium hydroxides; very slightly soluble in water and in al- having a slightly sweet taste. he United States Pharmacopeia (USP) held the workshop “Solubility Criteria for Veterinary Products” on November 7–8, 2012, at USP headquarters (1). �w1.�� �L��!����Ěx�:Qf:��P��7I��2gn(0XW�)Q�� �xJT����k �ٸF�w�_3>�U��=Z�;�OF;��m�VgKn��L�[/�U�­�OͭT�8�(�4埌[�+�W;��}jM�)֭��ֲnMܞ%�?�hO�R�Wl���/�|��G���p����G�%?�Z{5�j��=�Z��֘�]Ժ���9��_*�$}4�����}��>�f2|,�ֲO�����x������W�=�sX�̯�? )�� �0���x}.^��������k��O����f>m�b@��~�2��B��Kp���U�ׯ���J��Wm��z�j+� is determined by the volume of an aqueous medium sufficient to dissolve the highest dose strength of a dosage form across a pH range of 1.2–7.5. %PDF-1.6 %���� �ʕ��x-�� g���� ծ��M����+�B7�?D��$8G��k�D"�C���Re��P�*�����oT�s�&�j�Dt�P5#�k�^�y�:�ER��J"��M���H�W���g�U���Q����h�`N��� �jb�}��,��-�x�R+����^�� U��a�x8��69��!�ĉ1��z|G���?�~�

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