724 0 obj <> endobj endstream endobj h��Wmo�8�+��b��f��I�f[{E��䃗h��l�������I��ހ�!��H�EI�sa�s\•�G����!q��K�)F� gN||JΤB��!�uAD)"�������O�t�^ +.#�ϟ�8K���eXF%�\�ܘiw�YZ��|΍���43�aL��c���ḵ�5Ğx�g�P�z;�ҹ~.��������kP͑q J��%?���@\N�Q�^�� :���4����dG�J�% ���������q�����c f�N����4� 2007-06-11T14:04:15+02:00 • USP 1092 1.1 Performing Filter Compatibility 1.2 Determining Solubility and Stability of Drug Substance in Various Media 1.3 Choosing a Medium and Volume 1.4 Choosing an Apparatus • METHOD DEVELOPMENT 2.1 Deaeration 2.2 Sinkers 2.3 Agitation 2.4 Study Design 2.4.1 Time Points 2.4.2 Observations 2.4.3 Sampling 2.4.4 Cleaning Dissolving procedure Shake vigorously for 1 min and place in a constant temperature device, maintained at a temperature of 25.0±0.5°Cfor15min.Ifthesubstanceisnotcompletely The reference table is intended primarily for those who use, prepare, and dispense drugs and/or related articles. %verypdf.com $V�*[���{��0��P��� Standard buffer solutions described in the USP are h�bbd```b``��� �q?�d}"Y��l�`�N0{X�-�]_f����Ȓ* ���v]"E�A$W+Xo��?ӏ����)l/#M��: pS 4 0 obj<> endobj 9 0 obj<> endobj Solubility data is a key parameter in selecting the composition and volume of medium to be used in dissolution or in vitro release testing. This chapter provides an overview of the concepts and equations related to thermodynamic equilibrium and solubility. The focus will be on determining crucial factors that might affect the method. �� E���a��ay��d�$�*0z���\�I[ �Ea�B��7B5W���?FI��#�W+��8���F�1���M�0�(�$�(. 1 0 obj<> endobj ���)ʥ��>ݽs�pvu�,���r��n ��C�ia7Y4��H��PNgM�l���>[�l}")��N�ٖ��Җ�f ��Sn��n��Rq*��� ]���vA�,���%zlՔi�V�Y�(ʸ��&��͖�ӵݼ�x��M)vsJ{�Dx��B�k���H"��` �F��_. The ability to accurately measure the aqueous solubility of a material is affected by the physico-chemical properties of the material (e.g., surface area, particle size, crystal form), the properties of the solvent (e.g., pH, polarity, surface tension, added surfactants, co-solvents, salts), and the control of the solubility measurement parameters (e.g., temperature, time, agitation method). The literature values of pKa lit , intrinsic solubility, S 0 lit , and experimental intrinsic solubility, S 0 exp , developed from solubility-pH profile at two temperatures, 298.2 and 310.2 K 2 0 obj<> endobj 2007-05-30T17:22:21+03:00 SOLUBILITY For this test a maximum of 111 mg of substance (for each solvent) and a maximum of 30 ml of each solvent are necessary. yȮp�s�y���\Ut�P������eM�*]���;�j���9ua�n]�L+o�V�i�Z�\��e��f:�w�5�R-�� %�ٶ]�Pw���Z���+:��Ja��7ӗE�J�LF�Sd�#���_�0�M3z}�&�={�"w�����E^�Ƴ���v���֣" �a0dj��~� �{��PޑV�_���EQ��[���3W�w�*u^��a�59ΰ�+�#�k�)��utt��x���51#�N$kڦ ��< �0���.�fA. However, they may indirectly help in the preliminary evaluation of the integrity of an article. %PDF-1.4 17 0 obj<>stream Pharmacopeial area and a make a pre-study of the rotating disc. The reference table merely denotes the properties of articles that comply with monograph standards. Apparatus * Constant-Temperature Bath— Use a constant-temperature bath that is capable of maintaining the temperature within ±0.1 and that is equipped with a horizontal shaft capable of rotating at approximately 25 rpm. 2007-06-11T14:04:15+02:00 There is no substantial analysis performed on the Shear distributions for USP 25, the rotating disc. 80 ± 2 per cent relative humidity. Information about an article's “description and solubility” also is provided in the reference table Description and Relative Solubility of USP and NF Articles. • USP 1092 1.1 Performing Filter Compatibility 1.2 Determining Solubility and Stability of Drug Substance in Various Media 1.3 Choosing a Medium and Volume 1.4 Choosing an Apparatus • METHOD DEVELOPMENT 2.1 Deaeration 2.2 Sinkers 2.3 Agitation 2.4 Study Design 2.4.1 Time Points 2.4.2 Observations 2.4.3 Sampling 2.4.4 Cleaning Pharmacopeial area and a make a pre-study of the rotating disc. 134 single therapeutic dose of the API (in mg) at the pH of lowest solubility. %PDF-1.5 %���� The “description” and “solubility” statements pertaining to an article (formerly included in the individual monograph) are general in nature. 744 0 obj <>/Filter/FlateDecode/ID[<9CA933CE75B1004B90901D9CCEF07966><4B95935A2AE6D24DAFF513C4EEF8DE35>]/Index[724 38]/Info 723 0 R/Length 104/Prev 510855/Root 725 0 R/Size 762/Type/XRef/W[1 3 1]>>stream There is no substantial analysis performed on the Shear distributions for USP 25, the rotating disc. The water solubility, hygroscopicity, solubility in organic solvents, and melting point do not vary in the specified molecular weight range. pKa – 1, and at pH = 1 and 7.5. endstream endobj startxref %%EOF 135 A study report should be created after the experiment detailing the actual experimental conditions, 136 results (raw data plus mean values with standard deviations) and any observations such as, for 137 example, the degradation of an API due to pH or buffer composition. ���ϳ���uH!f�p�fwm����(���̮ĉ�X8�h���h�闯���G�x=7�a��r�Ho�|%f��Z�A�2J��(}H4a4,�����YdE��x[f9����C�/5Kd�|��8}�0[��q�rF��C\�9��ξ�3>m���`h�l. The U. S. Pharmacopeia is proposing the new General Chapter <1236> Solubility Measurements (2). 16 0 obj[/Indexed/DeviceRGB 253 28 0 R] endobj At concentrations of about 20% polymer in water, the solutions are nontacky, reversible, elastic gels. The focus will be on determining crucial factors that might affect the method. �1WI����9>�_R"d��IJ�%�!`�JiHh=`C�}H�"��E�(d�Y��w �Էd] d��M���=C�� 6�aL$�(GB)8�aoʼn�Q�#n�R�ܸ���T�Vp��ogT��Q�)moIԜj���+|�u�������Q"��=~Q5'�Mn������ �u�l���C�+ t ��5!B���7 �[��/�K��a�tFW�te������=:;@݀�gN�9�&9,;��"�W�uB��7 `&�� �M�Iq{la`����j-%����L�ܳ����f��x�����&X�I�Fp)D[]���U�XV�б],ޞa%��I5di/,fqI�'9@�}��K�8����O��f#�A�����{�g4�.���mæi�>f�F�-��ɚD��FUҨ���mH��|I�h�Ͻ���x����C�@�,��&&$8�*4̆�}^Hz ���Ic�p�/�\�