3 0 obj endobj >> /MediaBox [0.000 0.000 1224.000 792.000] endobj endobj >> endobj [/PDF /Text ] /Kids [6 0 R 5 0 obj << /Type /Pages 14 0 R /Count 2 ¾Equilibrium (= thermodynamic) solubility (S) the concentration of compound in a saturated solution when solid is present and solution and solid are at equilibrium ¾Intrinsic solubility (So) the equilibrium solubility of the free acid or base form of an ionizable compound at a pH where it is fully unionized ¾Apparent solubility (SpH) The similarities to USP Apparatus II ... solubility and bulk concentration respectively, A is the surface area and h is the diffusion layer thickness. stream /Contents 7 0 R The U. S. Pharmacopeia is proposing the new General Chapter <1236> Solubility Measurements (2). << /Type /Outlines /Count 0 >> 83 Measurements should be made in triplicate under at least three pH conditions, pH 1.2, 4.5 and 6.8 82 The pH-solubility profile of the API should be determined over the pH range of 1.2–6.8. /F2 9 0 R %PDF-1.3 /Resources << 83 Measurements should be made in triplicate under at least three pH conditions, pH 1.2, 4.5 and 6.8 Defined in USP <1236> Dissolution is the non-equilibrium process of approaching the solubility limit at thermodynamic equilibrium (i.e., the solute and solvent forming a uniformly mixed solution). 4 0 obj Description and Relative Solubility of USP and NF Articles. << /Type /Page << SOLUBILITY o Thermodynamic Solubility o Kinetic solubility 6 7. This chapter provides an overview of the concepts and equations related to thermodynamic equilibrium and solubility. Solubility data is a key parameter in selecting the composition and volume of medium to be used in dissolution or in vitro release testing. endobj 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). Description and Relative Solubility of USP and NF Articles The “description” and “solubility” statements pertainingand other particulate matter, unless limited or excluded by to an article (formerly included in the individual mono- definite tests or other specifications in the individual >> /MediaBox [0.000 0.000 1224.000 792.000] /Title (�� V i e w P D F) • 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 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. 3 + C P D F) Descriptive term: Part of solvent required per part of solute: Very soluble: Less than 1: Freely soluble: From 1 to 10: Soluble: From 10 to 30: Sparingly soluble: From 30 to 100: Slightly soluble: From 100 to 1000: Very slightly soluble: From 1000 to 10,000: Practically insoluble: 10,000 and over: Follow us: USP & IP Solubility Criteria 7 Description Parts of solvent required for one part of solute Very soluble < 1 Freely soluble 1 - 10 Soluble 10 - 30 Sparingly soluble 30 - 100 Slightly soluble 100 - 1000 Very slightly soluble 1000 - 10,000 Insoluble > 10,000 8. 3.1 Intrinsic rate of dissolution x��Zےܶ}�W�Q�Z�$x]�TY7;�r��*O��3�YZ3�1��z�!�ޜ�p����6@��n�A�4I�T�O����٫*/�4�T�ˤ�k�a��{�Uf�T}�W����t^�]���]���'�K�N�;t�yz���z��ٵ����F=�T��~U�7��}���$�juP�TI�?�W���Kg+�'yVzg�w��өSýz?Ls�}���⌂�\�ūՏݱ۽z�О�nT��a:u��g�z8�y�.��:iL�\���O_�. /ProcSet 4 0 R << /Type /Catalog Nifedipine is a dihydropyridine calcium channel blocking agent. The similarities to USP Apparatus II (same vessel as the rotating disk but a paddle ... solubility and bulk concentration respectively, A is the surface area and h is the … /ModDate (D:20201129023900-05'00') ] /Annots [ 10 0 R 12 0 R ] Hot Water— The uses of this water include solvents for achieving or enhancing reagent solubilization, restoring the original volume of boiled or hot solutions, rinsing insoluble analytes free of hot water soluble impurities, solvents for reagent recrystallization, apparatus cleaning, and as a solubility attribute for various USP–NF articles. /F1 8 0 R Nifedipine inhibits the transmembrane influx of extracellular calcium ions into myocardial and vascular smooth muscle cells, causing dilatation of the main coronary and systemic arteries and decreasing myocardial contractility. 82 The pH-solubility profile of the API should be determined over the pH range of 1.2–6.8. 7 0 obj endobj USP and BP solubility criteria. << /Filter /FlateDecode /Outlines 2 0 R There is no substantial analysis performed on the Shear distributions for USP 25, the rotating disc.