PHA 039: P1, 2, & 3

• Measurand


  The chemical entity being investigated
• Analyte


  The chemical entity being investigated
• Active Pharmaceutical Ingredients (APIs)

  Any substance that is responsible for the therapeutic effect of the drug
• Excipients


  Starting materials, such as reagents and solvents, used in the production of intermediates or APIs
• Clean Area


  Premises that provide complete separation of all aspects of an operation
• Airlock


  The enclosed space which serves as controlled environment or barrier and helps maintain the integrity of clean or controlled areas
• Pharmacopeia


  The legal and official book of drug standards their formulas, methods for making medicinal preparations and other related information
• Monograph


  A document that contains the name of the ingredient, definition, preparation, storage, packaging, and labeling requirements. It also specifies all the tests conducted to be conducted on a product
• Good Manufacturing Practice (GMP)


  It is part of the quality assurance which ensures that products are consistently produced and controlled to the quality standard
• Accuracy


  A parameter that denotes the nearness of the experimental data to the true value
• Content Uniformity


  Range of acceptance criteria: 80-120%
• Dissolution testing


  Range of acceptance criteria: 70-130%
• Trace


  Constituent type if analyte level is <1pbb
• Validation


  Process by which it establishes that the performance characteristics of the analytical method meet the requirements
• Calibration


  A procedure ensuring that a particular instrument results within specified limits in comparison to those by a reference standard
• Malachite green


  Acts as a local antiseptic which is effective against fungi and gram positive bacteria
• Phenolphthalein


  Commonly used indicator in acid-base titrations, used as a potent laxative before
• Malachite green


  Also called aniline green, prepared from benzaldehyde and dimethylaniline, used medically in dilute solution as a local antiseptic effective against fungi and gram-positive bacteria
• Physicochemical theory of indicators


  Attributes the color to the increase or decrease of hydrogen ions which causes appearance and disappearance of color in the solution
• Organic theory of indicators


  Attributes the observed color changes to specific functional groups or molecular structures within the indicator molecule
• Indicators used when a strong acid is titrated with a strong alkali or vice versa


  • Phenolphthalein
  • Methyl red
  • Methyl orange
  • Methyl yellow
• Indicators used when a weak alkali is titrated with a strong acid


  • Phenolphthalein
  • Methyl red
  • Methyl orange
  • Methyl yellow
• Indicators used when a weak alkali is titrated with a weak acid, or vice versa


  • Phenolphthalein
  • Methyl red
  • Methyl orange
  • Methyl yellow
• Buffer solutions


  Solutions that resist drastic changes in pH
• Heparin is subjected to preclinical trials on rabbits
• Henderson-Hasselbalch Equation


  Used in the preparation of drug solutions at a desired pH using both neutral and the salt forms of a drug
• Van Slyke Equation


  Gives the relationship between buffer capacity and buffer concentration
• Common Ion Effect


  Describes the effect on equilibrium that occurs when a common ion is added to a solution
• Le Chatelier's Principle


  If a dynamic equilibrium is distributed by changing the conditions, the position of equilibrium shifts to counteract the change to reestablish an equilibrium
• Physiologic buffers present in Urine

  • Ammonia
  • Phosphate
• Major buffers present in Blood

  • Bicarbonate Buffer System
  • Plasma Protein
  • Hemoglobin
• Primary standard


  Chemical solution that have already been attained 100% purity and does not require standardization
• Gravimetric analysis


  Analysis wherein the constituents of a sample are separated and the product is weighed
• Titrant


  Reagent of known concentrations that is determined by standardization
• Titrand


  Solution of unknown concentration that is being analyzed in the titration process
• Standardization


  Process of determining the exact concentration of the titrant using standards
• Equivalence point


  Point in a titration when the amount of added standard reagent is chemically equivalent to the amount of analyte
• End point


  Point at which the reaction is observed to be complete
• Acidimetry


  Measurement of a base of a given sample titration with a standard acid
• Alkalimetry


  Measurement of an acid of a given sample titration with a standard base