BP & Pharmaceutical Analysis

Question 1

Give examples of impurity sources

Answer 1

• Raw materials
• Manufacturing method
• Decomposition
• Environment

Question 2

Which characteristics need to be checked?

Answer 2

• Identity, purity, uniformity
• Potency, efficacy, toxicity
• Packaging, labelling, storing, stability

Question 3

What requirements do the pharmacopoeias define?

Answer 3

• Quantitative and qualitative composition of medicines

- tests to be carried out on medicines and substances and other materials used in production

Question 4

Which are the 3 pharmacopoeias?

Answer 4

European Pharmacopoeia
British Pharmacopoeia
Veterinary British Pharmacopoeia

Question 5

Does the British pharmacopoeia take precedence over the European one?

Answer 5

No - European takes precedence over British

Question 6

What is in a monograph?

Answer 6

Description of product
Identification tests
Physical constants 
Minimum purity standards and assay of active 
Pharmaceutical ingredients 
Limit test - controls impurity levels 
Storage conditions

Question 7

Are statements of solubility official requirements?

Answer 7

No - they are just a guideline except for when they are specified elsewhere e.g. under headings like solubility in ethanol

Question 8

Are identification tests absolute proof?

Answer 8

No - they are only used to verify that the identity is according to the label claim