analysis part 2

• QUALITY – sum of all factors which contribute directly or indirectly to the safety, effectiveness, and reliability of the product.
• • QUALITY CONTROL - is the sum of all tests performed to determine the conformance of the product to specification.
• • QUALITY ASSURANCE - is the sum of all processes perform to ensure that the product posses all the characteristic it is attended to have.
• Active ingredient- A substance or bulk pharmaceutical chemical that is intended to furnish pharmacological activity.
• Adulterated substance- A material that has either been contaminated

  with a foreign substance or not manufactures using good manufacturing

  practices.
• Assay – provide an exact result, which allows an accurate statement on

  the content or potency of the analyte in the sample.
• Batch (Lot) - A defined quantity of raw material, intermediate material,

  packaging components, or final products processed so that it expected

  to be homogenous.
• Batch number (Lot number) - A distinctive combination of numbers or

  letters from which the complete history of the manufacture, processing,

  packing, coding, and distribution of a batch can be determined.

   
• Batch numbering system- A standard operating procedure (SOP)

  describing the details of assigning batch numbers.
• Batch record- Documentation that provides the history of a batch from

  the raw material stage to completion of the batch or lot.

   
• Blank Determination- The determination is to be conducted using the

  same quantities of the same reagents treated in the same manner  as the

  solution or mixture containing the portion of the substance under assay or

  test, but with the substance itself omitted.
• CGMP (Current Good Manufacturing Practice) – regulatory guidelines

  promulgated by the FDA which made the strongest impact on the drug and

  cosmetic industry.  As the word implies current means dynamic, changing

  as the occasion arises (the need for technical improvement and for greater

  protection of the consumer)
• Desiccator- The use of tightly closed container of suitable size and design

  that maintains an atmosphere of low moisture content by means of silica gel or other suitable desiccant.
• • Vacuum Desiccatoris one that maintains the low-moisture atmosphere at

  a reduced pressure of not more than 20 mm of mercury or at the pressure

  designated in the individual monograph.
• Dried to constant weight-  two consecutive weighting do not differ by  more than 0.5 mg/g of substances taken for the determination, the second weighing following an additional hour of drying.

   
• Expiration date- The date beyond which the product may no longer conform

  to the relevant specifications.

   
• Mesh - The number of linear openings per square inch.
• Fume Hood – laboratory equipment designed to limit person’s exposure to hazardous fumes
• Negligible- this term indicates a quantity not exceeding 0.50 mg.
• Packaging Material - The containers, closures, and labels employed in the packaging of the product.

   
• Returned Products- Finished products sent back to the manufacturer.
• Shelf Life- The length of time during which the product exhibits stability.
• Specifications- The quality parameters that serve as a basis for quality evaluation and to which the products or materials must conform.
• Specificity – ability to assess unequivocally the analyte in the presence of components that maybe expected to be present such as impurities, degradation products, and matrix components

   
• Stability- The continued conformance of the product to its specifications.

   
• Standard operating Procedures (SOPs)- A written authorized procedure that gives instructions for performing operations.
• Torque - is a measure of how much a force acting on an object causes that object to rotate
• Validation- Documentation that states that any procedure, process, equipment, material, or activity consistently leads to the expected results.
• ANALYTE OR  ACTIVE CONSTITUENTS – chemical substances being analyzed.
• TITRANT -  solution of known concentration usually added by means of a buret.
• TITRATION – the act of adding and measuring the volume of titrant used in the assay.
• INDICATOR – a chemical which changes color at or very near the point in the titration where equivalent quantities of analyte and titrant have reacted.
• STOICHIOMETRIC POINT OR EQUIVALENCE POINT – theoretical point at which equivalent amounts of a titrant and analyte have reacted.
• END POINT – titration is actually stop at some point at which there occurs

  a sudden change in some property of the reaction mixture.
• Visual

  • Use of indicators (type of indicators)
• Amperometric/Electrometric/Conductometric

  • High-frequency titration (type of endpoint)
• STANDARD SOLUTION – solution of known normality or molarity.

   
• NORMALITY – the number of equivalents of solute per liter (equiv/liter) or milliequivalent per milliliter (meq/ml) of a solution.
• MOLARITY – expression of the concentration of a solution in terms of moles per liter.
• Quality Assurance- part of quality management focused on providing confidence that quality requirements will be fulfilled"