Prelims

• means analysis of a pharmaceutical’s?

  pharmaceutical analysis
• it is Safe, effective and quality produced meds?

  quality assurance
• It is safe, effective and quality medicines all throughout production?

  Quality control
• this activities include a planned system of review procedures conducted by personnel not directly involved in the inventory compilation/development

  process?

  Quality Assurance Activities
• this verify that data quality objectives were met, ensure that the inventory represents the best possible estimates of emissions and sinks given the current state of scientific knowledge and data available, and support the effectiveness of the QC

  program?

  Reviews
• is of suitable quality to provide an effective outcome?

  Product
• they have properly instructed patient how to use the product, Patient complies with the prescribed regimen correctly?

  Prescriber/Dispenser
• it is a system of routine technical activities, to measure and control the quality of the inventory as it is being developed?

  Quality control
• it includes general methods such as accuracy checks on data acquisition and calculations and the use of approved standardised procedures for emission calculations, measurements, estimating uncertainties, archiving information and

  reporting?

  Quality control
• is a collection of legally binding standards, in most cases prepared by a national or regional authority?

  pharmacopeia
• translated from Greek as “drug-making” or “to make a drug” ?

  pharmacopeia (also spelled pharmacopoeia)
• included the names of and preparation methods for herbal remedies commonly used in ancient Greece and Rome.?

  De Materia Medica
• translated as “on medicinal materials” from Latin?

  De Materia Medica
• An analyte is chemically reacted with a standard solution of a reagent of precisely known concentration or with a concentration that can be precisely determined?

  Titrimetric Methods
• is normally used to express the content of active ingredient in liquid formulations such as injections, infusions and eyedrops?


  Percentage weight in volume (%w/v)
• it Indicates how responsive it is to a small change in the concentration of an analyte?

  Sensitivity
• measure of how capable it is of measuring the analyte alone in the presence of other compounds contained in the sample. The most selective analytical methods involve a chromatographic separation?

  Selectivity
• Determine how resistant the precision and accuracy of an assay is to small variations in the method?

  Robustness
• it Can be applied to instrument performance (dynamic range)?

  Range
• Most analytical methods are based on processes where the method produces a response that is linear and which increases or decreases linearly with analyte concentration?

  Linearity
• should reflect all the processes to which the

  analyte in a real assay is subjected and not be a simple dilution of a pure standard for the analyte until it can no longer be detected?

  limit of detection
• simplest method is to determine __ of the substance being analysed with a reference standard analysed by the same procedure?

  accuracy
• Expresses the precision between laboratories?

  Level of Precision: Reproducibility
• expresses the precision obtained under the same operating conditions over a short interval of time. AKA intra-assay precision?

  Level of precision: Repeatability
• Exact description of how the analysis is carried out?

  Analytical Procedure/Method
• Provide standard pharmacopeial methods for the assay of unformulated drugs and excipients and some formulated drugs, e.g. those that lack a

  strong chromophore?

  Titrimetric Methods
• • Capable of a higher degree of precision and accuracy than instrumental methods of analysis, with precisions of ca + _0.1% being achievable.
  • The methods are generally robust.
  • Analyses can be automated.

  Titrimetric Methods
• Radiation in the wavelength range 200–700 nm is passed through a solution of a compound, The electrons in the bonds within the molecule become excited so that they occupy a higher quantum state and in the process absorb some of the energy passing through the solution?

  Ultraviolet and Visible Spectroscopy
• Electromagnetic radiation ranging between 2500 and 20 000 nm is passed through a sample

  and is absorbed by the bonds of the molecules in the sample causing them to stretch or bend.

  The wavelength of the radiation absorbed is characteristic of the bond absorbing it?

  Infrared Spectrophotometry
• Electromagnetic radiation in between 1000 and 2500 nm is weakly absorbed by the X—H bonds

  of molecules, causing them to stretch. The wavelength of the radiation absorbed is characteristic of the bond absorbing it?

  Near-Infrared Analysis
• The analyte is loaded onto the head of the column via a loop valve and separation of a mixture occurs according to the relative lengths of time spent by its

  components in the stationary phase?

  High-Performance Liquid Chromatography
• An analyte migrates up or across a layer of stationary phase (most commonly silica gel), under

  the influence of a mobile phase (usually a mixture of organic solvents), which moves through the stationary phase by capillary action?

  Thin Layer Chromatography
• Analytes migrate in the applied electric field at a

  rate dependent on their charge and ionic radius. The mobile phase generally contains an aqueous

  component and must contain an electrolyte?

  High-Performance Capillary Electrophoresis
• are easily recognized since they involve a major

  breakdown in the analytical process such as samples being spilt, wrong dilutions being prepared or instruments breaking down or being used in the wrong way?

  Gross errors
• • lead to fluctuations around the true value as a result of difficulty taking measurements essentially unavoidable
  • unpredictable
  • affects measurements in different directions, canceling out the errors in the long run

  Random errors
• lead to a predictable and consistent departure from the true value avoidable produce consistent errors

  affects all measurements consistently in the same direction, leading to biased result?

  Systematic errors
• is determined by closeness to standard value?

  Accuracy
• it is often expressed as the relative standard deviation (RSD)?

  precision of an analysis
• • Exact description of how the analysis is carried out.
  • Describe in detail the steps necessary to perform each analytical test.

  Analytical Procedure/Method