(1)Analytical Chemistry & Pharmaceutical Analysis

allelipraise's version from 2018-06-06 11:19

Section 1

Question Answer
Pharmaceutical analysisa branch of practical chemistry that involves a series of processes for identification, determination, quantification and purification of a substance, separation of the components of a solution or mixture or determination of structure of chemical compounds
Quality(as applied to a drug product) the sum of all factors which contribute directly or indirectly to the safety, effectiveness, and reliability of a product (responsible of all persons involved in manufacturing.)
Quality Control guarantees within reasonable limits that a drug product is free from impurities, physically and chemically stable, contains the amount of active ingredients as stated on the label
Assayinga quantitative analysis performed to establish the proportion of the essential component
Qualitative analysisestablishes the chemical identity of the species in a sample
Quantitative analysisdetermines the relative amounts of theses species (analytes) in numerical terms.
Analytescomponents of a sample that are to be determined

Section 2

Question Answer
QualityThe degree to which a set of inherent properties of a product, system or process fulfills requirements
Characterisation Analysisan analysis which we evaluate a sample's chemical or physical propterties
Fundamental Analysisan analysis whose purpose is to improve an analytical method's capabilities
Quality Assurance the sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained
Quality Controlchecking or testing that specifications are met, ensuring purity, stability, identity, potency, and bioavailablity of the drug
Acceptance criterianumerical limits or ranges or other suitable measures for acceptance of test results
QA and QCquality-related activities should be defined and documented, specifically, recorded at the time they are performed
Quality Unita unit independent of production that fulfils both quality assurance and quality control

Section 3

Question Answer
Product Quality Reviewconducted with the objective of verifying the consistency of the process
Methods of Drug AnalysisNature of Sample/ Size of Samples/ Extent of Analysis
Classical Methods (Total Analysis Techniques)techniques responding to the absolute amounts of analytes with a few exceptions, the signal results from one or more chemical reactions involving the analyte, such as precipitation, acid–base, complexation, or redox chemistry
Physicochemical Methods (Instrumental / Concentration Techniques)techniques that rely on measuring an optical or electrical signal the signal is proportional to the relative amount of analyte in a sample
Special MethodsRequires a distinct type of technique
Alkaloidal Assaying Example of Special Methods
Spectrometry/Potentiometry/VoltammetryExample of Physicochemical Methods
Acid-Base/Redox/PPT/ComplexationExample of Classical Method

Section 4

Question Answer
Macroanalysis(Size of Sample) >0.1g
Mesoanalysis (Semimicroanalysis)(Size of Sample) 0.1g to 1g
Microanalysis(Size of Sample)0.01 g to 0.1 g (10mg to 100mg)
Submicroanalysis(Size of Sample) 0.001 g to 0.01 g (1 mg to 10 mg)
Ultramicroanalysis(Size of Sample)< 0.001 g

Section 5

Question Answer
Major constituent (Size of Sample)1 to 100% of the sample
Minor constituent (Size of Sample) 0.01 to 1%
Trace constituent (Size of Sample)< 0.01%
Trace constituent (Size of Sample)10^2 to 10^4 μg per gram (ppm)
Microtrace constituent (Size of Sample)10^-4 to 10^-7 ppm
Nanotrace constituent (Size of Sample)10^-7 to 10^-10 ppm

Section 6

Question Answer
Proximate analysis in which the amount of each element in a sample is determined with no concern as to the actual compounds present
Partial (Ultimate) analysiswhich deals with the determination of selected constituents in the sample
Trace constituent analysis a specialized instance of partial analysis in which we are concerned with the determination of specified components present in very minute quantity
Complete analysiswhen the proportion of each component of the sample is determined

Section 7

Question Answer
AccuracyDegree of agreement of your results to the true value (official or theoretical requirement)
PrecisionDegree of agreement of your results in comparison to all the trials performed