The reference table is intended primarily for those who use, prepare, and dispense drugs and/or related articles. Allow to stand for 24 h. ... 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. The reference table merely denotes the properties of articles that comply with monograph standards. 5350Description and Solubility / Reference Tables First Supplement to USP 35–NF 30 DESCRIPTION AND SOLUBILITY Description and Relative Solubility of USP and NF Articles The “description” and “solubility” statements pertainingand other particulate matter, unless limited or excluded by There is no substantial analysis performed on the Shear distributions for USP 25, the rotating disc. Depending on study variability, additional replication may be necessary to provide a reliable estimate of solubility. 15 0 obj<> endobj The water solubility, hygroscopicity, solubility in organic solvents, and melting point do not vary in the specified molecular weight range. 2007-06-11T14:04:15+02:00 {�32�����zr{��5Q�~b� endstream endobj 4 0 obj<> endobj uuid:38bb500f-f0d5-4fbc-906f-f0051166d996 The similarities to USP Apparatus II (same vessel as the rotating disk but a paddle �:��"L%{qR�|�B4"2�9J!��R-�UU�SČ%5 ��$��8�(&�uZ���T4FP2�(�%�=���}�`�d�ImhWe�oY,���QY�?�|F�h=@4� ���I�Q�{�989������Z�%U��⼐��q7�)��Q�/�*>s�iZQ� �l⪁c����4��� The focus will be on determining crucial factors that might affect the method. f+�)����抻�Bx�+����d��g����1�@��Y�C/+�@��1Hz�w�����gȅ�4ꔖ&����i���ܝ� %PDF-1.4 12 0 obj<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC/ImageI]/ExtGState<>>> endobj p�m�g�;F=PR�����(&���e6MW�����*��[)I���_I�i� �_6�T��Ĵ?�� qDE�l�i ��ߏ@�o���U2=`��s���W��R B@���odñ���J��$!k�^�E!K�xu�������,rb���s#���E>Sr0�ғ`�xJVF�=a�7��z+�r�Q�Š��$C�6[Bg�9�Z X�5B>S%�t��x�C�ySӂ��%�3_�E�k� ���J�. (4) A solubility of 10 mg to 20 mg per g is optimal, but a wider working range can be used. This chapter provides an overview of the concepts and equations related to thermodynamic equilibrium and solubility. 16 0 obj[/Indexed/DeviceRGB 253 28 0 R] endobj h�bbd```b``��� �q?�d}"Y��l�`�N0{X�-�]_f����Ȓ* ���v]"E�A$W+Xo��?ӏ����)l/#M��: pS 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). pKa – 1, and at pH = 1 and 7.5. At room temperature polyethylene oxide is miscible with water in all proportions. The information is provided for those who use, prepare, and dispense drugs, solely to indicate descriptive and solubility properties of … $V�*[���{��0��P��� 10 0 obj/Encoding<>>>>> endobj At concentrations of about 20% polymer in water, the solutions are nontacky, reversible, elastic gels. 3 0 obj<> endobj Information about an article's “description and solubility” also is provided in the reference table Description and Relative Solubility of USP and NF Articles. �1WI����9>�_R"d��IJ�%�!`�JiHh=`C�}H�"��E�(d�Y��w �Էd] d��M���=C�� 6�aL$�(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�/�\� 1 0 obj<> endobj %verypdf.com Pharmacopeial area and a make a pre-study of the rotating disc. 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. Trace impurities may affect solubility greatly. 724 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. A minimum of three replicate determinations of solubility in each pH condition is recommended. 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 2007-05-30T17:22:21+03:00 application/pdf However, they may indirectly help in the preliminary evaluation of the integrity of an article.
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