Med Chem - Quality Assurance Flashcards
What are the 5 key components of GMP?
- Starting materials -> pure
- Premise and Equipment -> maintained
- People -> trained to be competent
- Technology and science -> the latest
- Documentation of processes -> to show compliance
Who is the ICH?
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
Standardizes requirements for medicines regulation around the world. For identification tests, quantitative tests (impurities), limit tests (impurities), quantitative tests (API, drug products, selected components).
How may the Manufacturing Process itself introduce impurities?
- particulates
- cross-contamination
- microbial contaminations
- packing errors
- process errors
How may Storage Conditions introduce impurities?
- filth
- chemical instability
- reaction w/ container materials
- physical changes
- temperature effects
What is a Limit Test and what is its role?
a quantitative or semi-quantitative test designed to identify and control small quantities of impurity. Eg. a set amount of time required to react with a definite amount of impurity.
List 3 types of Limit Tests.
Testing for the limits of:
- insoluble matter
- soluble matters
- moisture, volatile matters, residual solvents
- non-volatile matters
- loss on ignition -> limits of residue on ignition and ash values (indicates contamination)
- precipitation methods
What are the tests used to identify a drug?
- Infrared absorption test -> by fingerprint region
- UV absorption test -> compare maxima and minima at the same wavelength, and absorptivities +/- absorbance ratios are within specified limits.
- Thin-layer Chromatography test -> find Rf value (ratio of solute’s distance travelled to solvent’s distance travelled)
What assays for identification of a drug in loose powder / dosage form?
Loss on ignition?
List 3 types of titrations commonly found in pharmacopeia.
- Direct acid/base titration (aq phase)
- Indirect titration (aq phase)
- Argentometric titration
- Complexometric titration
- Redox titration
- Non-aq titration
- Potentiometric titration
What is the difference between direct and indirect titration?
Direct - the amount of reagent used is directly proportional to the amount of analyte.
Indirect - a fixed amount of reagent is added in excess to the analyte, and the amount of excess is then determined via titration.
When is indirect titration required?
1) Volatile analyte
2) Insoluble analyte
3) Analyte which reacts rapidly
4) Substance requires heating w/ a volumetric reagent. Decomposition or loss of reactants or products is expected. (hence need to react first before heating)
What are Primary standards and what is their role?
stable chemical compounds, high purity. Used to determine the correction factor.
What is a blank titration used for?
Done with no analyte. Used to account for changes to the reagent strength due to the experimental setup.
What is external standard and single point calibration?
External standard -> plot graph using multiple known concentrations of an analyte.
Single point calibration -> when only one concentration is used, and the AUC of this solution is compared to that of the analyte.
What are the requirements for a suitable internal standard?
- closely related in structure
- stable
- should be chromatographically resolved from the analyte and any excipients present in the chromatogram.
- should elute as close as possibletotheanalyte.
