W2.4_British Pharmacopoeia

Question 1

What does the BP contains? What are types of BP? Relate the BP to the legality in drug production. How are official names of drug compounds found in the BP?

Answer 1

• Covered in HMR 2012, contain standards for official medicinal products and pharmaceutical substances (in UK)
• BP (under MHRA), BP (Veterinary), EP (European, integrated with BP)
• Only official source of British pharmaceutical standards
• Comprises standards of substances used in practice of medicine/manufacture of medicine
• Title at head of each monograph: official name

Question 2

State the special publications under HMR2012. When is it illegal to produce drugs? What does it indicate when there is an EU logo in a monograph?

Answer 2

• Special publications under HMR 2012: BP, EP, Cumulative List of Recommended International Nonproprietary Names (INN)
  -> It is an offence to sell/supply/dispense a medicinal product if name is at head of a monograph in BP and does not comply with standards specified
  -> Monograph with EU logo = EP integrated into BP

Question 3

What are the purposes of BP (5)?

Answer 3

• Defines requirements for qualitative/quantitative composition of medicines
• Defines tests to be carried out on medicines
• Covers active substances/excipients/preparations
• Covers homoeopathic preparations/stocks/antibiotics/blood and plasma derivatives/vaccines/ radiopharmaceutical preparations
• Contains dosage forms and containers

Question 4

State the importance of analytical testing and impurities sources in drug production. What is the purpose of pharmaceutical analysis and how does it relate to BP monographs?

Answer 4

• Analytical testing is present in all stages of drug development
• Impurity sources: raw materials, manufacturing method, decomposition, environment
• Purpose: check identity/purity/uniformity, potency/efficacy/toxicity, packaging/labelling/storing/stability
• BP monographs: contain essential but not all tests that provide verification (qualitative) and identification tests for specific impurities (quantitative)

Question 5

Explain the special rules regarding solubility statements, identification tests, visual comparative tests, and assay in BP monographs.

Answer 5

• Solubility statements are just a guideline and not scientifically defined
• Identification tests are not absolute proof
• Visual comparative tests are conducted in Nessler cylinder (usually limit tests for impurities)
• Quantity taken for assay must not deviate by more than 10%, weighings accurate to +/- 5 units after last figure

Question 6

What are the general steps of analytical testing?

Answer 6

take representative sample (after grinding huge sample) -> extract analytes -> separate analytes -> identify, detect, and quantify analytes -> determine reliability/validity of results

Question 7

How should measurements be taken? Define precision and accuracy.

Answer 7

• Take reading as displayed in digital instrument/Go one more figure for scaled instrument
• Precision: how close measurements of same item are to each other
• Accuracy: how close measurements are to the true/accepted value

Question 8

Regarding precision, state the equations for standard deviation, sample mean, and relative standard deviation.

Answer 8

Standard deviation: sum of (value-mean)^2/N
Sample mean: average
Relative standard deviation: RSD=s/x *
100

Question 9

Regarding accuracy, state the equations for absolute and relative error.

Answer 9

x(i): observed value x(t): true value
Absolute error: E=|x(i)-x(t)|
Relative error: E(r)=|(x(i)-x(t))/x(t)| * 100%