Pharmaceutical Analysis

Question 1

What is pharmaceutical analysis?

Answer 1

The application of analytical procedures used to determine the purity, safety & quality of drugs.

Question 2

List 5 things that pharmaceutical analysis identifies.

Answer 2

1. Identify drug in formulated product.
2. Determine API & impurities
3. Stability of drug
4. Concentration of impurities
5. Concentration of drug in plasma or fluids.

Question 3

Describe the difference between qualitative & quantitative chemical analysis.

Answer 3

Qualitative - composition of substances & identifying compounds
Quantitative - estimating quantity of compound in a sample.

Question 4

What does the volumetric method include? What class is it?

Answer 4

Instrumental - acid/base, redox, precipitation

Question 5

What does spectral analysis involve? What class is it?

Answer 5

Instrumental - colorimetry 400-800nm, UV, infared, NMR, mass spectroscopy.

Question 6

What does the chromatographic method involve? What class is it?

Answer 6

Instrumental - separation of analyte dissolved into mobile phase & passes stationary phase. Planar or column.

Question 7

What does gas and liquid chromatography involve? What class is it?

Answer 7

Instrumental.
Gas - analytes that can be vapourised without decomposing. Absorbs at different rates.
Liquid - normal (mobile = non polar), reverse (mobile = polar) or ion exchange eg. HPLC.

Question 8

What method is used to separate proteins?

Answer 8

Electrophoretic techniques such as Gel Electrophoresis (SDS-PAGE)

Question 9

Describe 2 non-instrumental methods of analysis.

Answer 9

Biological - in vitro, animal study or microbiological assays that extract DNA and use PCR amplification to read and sequence.
Chemical - eg. volumetric, gravimetric & gasometric.

Question 10

List the 5 different methods of instrumental analysis.

Answer 10

1. Volumetric
2. Spectral analysis
3. Chromatography
4. Electrochemical
5. Hyphenated Techniques (GC-MS, LC-MS).

Question 11

List the 4 ranges of analysis.

Answer 11

1. Titration methods
2. Spectroscopic
3. Spectrometry
4. Chromatographic

Question 12

What does infrared spectroscopy identify?

Answer 12

Functional groups

Question 13

What does mass spectroscopy identify?

Answer 13

Mass to charge ratio

Question 14

Describe column chromatography.

Answer 14

Separates a single compound from a mixture based on adsorption to the adsorbent at different rates.

Question 15

What are the 5 types of column chromatography?

Answer 15

1. Size exclusion - molecules in ion solution are separated by size & MW.
2. Ion exchange - separates ions & polar molecules on affinity to ion exchanger.
3. Affinity - highly specific biological separation from a molecule in a complex mixture.
4. Partition - L-L chromatography
5. Adsorption - mobile and stationary phase, etc.

Question 16

What is the importance of biological testing and what does an assay reveal?

Answer 16

Qualitative determination of a specific characteristic of a product or container which a product is supplied. It says with a high degree of certainty the absence or presence of a type of activity or quality.