LEC1

Question 1

nature of sample

Answer 1

physical
chemical
biological

Question 1

The process of a quantitative determination of a chemical substance from a given sample.

Answer 1

assay

Question 2

size of sample

Answer 2

macroanalysis
semi-macroanalysis
microanalysis
submicroanalysis
ultramicroanalysis

Question 3

extent of analysis

Answer 3

proximate
ultimate
partial

Question 4

instruments, device

Answer 4

physical

Question 5

reagents, compounds, substances

Answer 5

chemical

Question 6

living organisms, urine, animals, microorganisms,

Answer 6

biological

Question 7

0.1g or more

Answer 7

macroanalysis

Question 8

0.1g - 1g

Answer 8

semi-macroanalysis

Question 9

0.01 g- 0.1g

Answer 9

microanalysis

Question 10

0.001 g - 0.01 g

Answer 10

submicroanalysis

Question 11

<0.001g

Answer 11

ultramicroanalysis

Question 12

amount of each element in a sample is determined

Answer 12

proximate

Question 13

the percent of extractive from a crude drug represents a SINGLE CHEMICAL SPECIES

Answer 13

ultimate

Question 14

determines selected constituents in the sample

Answer 14

partial

Question 15

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 (PIC/s cGMP 2018)

Answer 15

Quality Assurance

Question 16

• Checking or testing that specifications are met (PIC/s cGMP 2018)
• Ensures the safety, efficacy, stability and purity of raw materials and drug products.

Answer 16

quality control

Question 17

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.

Answer 17

Pharmaceutical Analysis

Question 18

• commonly involves analyses of raw materials, active pharmaceutical intermediates, ingredients excipients, (API’s), pharmaceutical substances and finished products.
• Pharmacopeia methods are performed according to the European Pharmacopoeia, the United States Pharmacopeia (USP), the British Pharmacopoeia, and the Japanese Pharmacopoeia among others.

Answer 18

Pharmaceutical Analysis

Question 19

Classification of Analytical Methods TECHNIQUES

Answer 19

separation
qualitative analysis
quantitative analysis

Question 20

Separation

Answer 20

Precipitation, extraction, distillation

Chromatography, electrophoresis

Question 21

Qualitative Analysis

Answer 21

Chemical tests, b.p., m.p., solubility, odor, optical activity, refractive index

UV/Vis spectrometry, infrared spectrometry, MS, NMR spectrometry

Question 22

Quantitative Analysis

Answer 22

Titrimetry, gravimetry,
coulometry

Potentiometry, voltammetry, spectrophotometry, AAS, thermometric methods, kinetic methods

Question 23

Securing or getting a representative sample from a given population
*Depends on material and quantity

Answer 23

sampling

Question 24

* Aka Random Error * Uncontrolled variable * Inherent error (always present and cannot be corrected) * Intangible

Answer 24

indeterminate error

Question 25

* Systematic Error * Flaw in equipment or design of the experiment

Answer 25

determinate error

Question 26

*Reproducibility of the result *Usually expressed as average deviation, standard deviation or range. *Standard Deviation *Relative Standard Deviation (or Coefficient of Variation) *Range –difference between the largest and smallest value.

Answer 26

precision

Question 27

*describes how close a measured value is to the “true” value

Answer 27

accuracy

Question 28

Difference between the mean value and true value

Answer 28

Absolute Error

Question 29

Absolute error divided by the true value

Answer 29

Relative Error

Question 30

measuring the volume of known concentration needed to react with analyte

Answer 30

Volumetric titrations

Question 31

mass instead of volume

Answer 31

Gravimetric titrations

Question 32

measure time required for complete electrochemical reaction

Answer 32

Coulometric titrations