BP & PHARMACEUTICAL ANALYSIS

Question 1

Where do impurities come from?

Answer 1

Raw materials, manufacturing method, decomposition, environment

Question 2

Which 10 characteristics need to be checked when manufacturing drugs?

Answer 2

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

Question 3

How do you extract and identify drugs?

Answer 3

UV, IR, TLC, spot test-extraction techniques

Question 4

How do you standardise reagents?

Answer 4

Volumetric analysis

Question 5

What Act establishes the legal status of the Pharmacopoeias and compendia?

Answer 5

Human Medicines Regulations 2012, and is covered in Part 15

Question 6

What requirements do the pharmacopoeias define?

Answer 6

• Quantitative and qualitative composition of medicinal products and pharmaceutical substances
• Tests to be carried out on medicines and substances and other materials used in production

Question 7

What are the 5 products the European/British Pharmacopoeia cover?

Answer 7

• active substances, excipients & preparations of chemical, animal, human or herbal origin
• homoeopathic preparations and homoeopathic stocks
• antibiotics
• dosage forms and containers
• includes texts on biologicals, blood and plasma derivatives, vaccines and radiopharmaceutical preparations

Question 8

Which are the 3 pharmacopoeias?

Answer 8

• European Pharmacopoeia
• British Pharmacopoeia (humans only)
• British Pharmacopoeia (veterinary)

Question 9

The European Pharmacopoeia is under the direction of…

Answer 9

The Council of Europe

Question 10

The British Pharmacopoeia is under the direction of…

Answer 10

of British Pharmacopoeia Commission Secretariat of MHRA

Question 11

The BP sits over the European pharmacopoeia. True or false?

Answer 11

False - EP sits over BP

Question 12

It is legal to sell, supply or dispense a medicinal product whose name is at the head of a monograph in BP, if the product doesn’t comply with the standards specified in that monograph. True or false?

Answer 12

False - it is an offence to do so

Question 13

What does it mean if a product is labelled BP?

Answer 13

Then the product must conform to standards in the current BP

Question 14

What does it mean if a product is labelled BP 1963?

Answer 14

The product must conform to standards in the 1963 BP

Question 15

Name the specified publications under HMRs 2012

Answer 15

• European Pharmacopoeia
• British Pharmacopoeia
• Cumulative List of Recommended International Non-proprietary Names (INN)

Question 16

Monographs in BP contain all tests that provide verification of the suitability of the product for pharmaceutical use. True or false?

Answer 16

False - contain essential, but not all tests

Question 17

What does MHRA stand for?

Answer 17

Medicines and Healthcare Products Regulatory Agency

Question 18

What is in a BP Monograph? (7)

Answer 18

• Description of the product
• Identification tests
• Physical constants (e.g. diffractive index)
• Minimum purity standards
• Assay of active pharmaceutical ingredients
• Limit test (controls impurity levels)
  Storage conditions (not always)

Question 19

In the BP, how should solubility statements in the characteristic section be treated?

Answer 19

They should be treated as guidelines and not official requirements

Question 20

In the BP, how should solubility statements under heading such as solubility in ethanol be treated?

Answer 20

They should be treated as official requirements

Question 21

What does soluble in the BP mean?

Answer 21

1g of solute dissolves in 10 to 30ml of solvent

Question 22

What does slightly soluble in the BP mean?

Answer 22

1g of solute dissolves in 100mL to 1L

Question 23

What does practically insoluble in the BP mean?

Answer 23

1g of solute dissolves in more than 10L

Question 24

Are identification tests absolute proof in the BP?

Answer 24

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

Question 25

What piece of apparatus does visual comparative tests take place in?

Answer 25

Identical tubes with a flat base tubes (Nessler cylinder)

Question 26

What are the rules for BP Assays?

Answer 26

Quantity taken for assay must not deviate by more than 10% from that stated

Question 27

What does the weight have to be accurate to, if you are weighing in accordance to BP rules?

Answer 27

The weight needs to be accurate to +/- 5 units after the last figure (e.g. 0.25g = 0.245 to 0.255g)

Question 28

When do you use a pipette, volumetric flask or burette to measure a volume?

Answer 28

If the figure after the decimal point is a zero or ends in a zero (for example, 10.0ml or 0.50ml)

Question 29

When do you use a graduated cylinder or graduated pipette to measure volume?

Answer 29

If the figure after the decimal point is NOT a zero or does not end in a zero

Question 30

When do you use a micropipette or micro syringe to measure volume?

Answer 30

For volumes stated in microliters

Question 31

When has a product dried?

Answer 31

When there is +/- 0.5mg diff in weight between two dryings.

Question 32

What does loss on drying reflect?

Answer 32

The net weight of a pharmaceutical substance under certain specified conditions of heat, pressure and duration.

Question 33

What is a limit test?

Answer 33

When standards are used to control the presence of toxic impurities.

Question 34

What is an example of a limit test?

Answer 34

Comparison of colour or turbidity of a prescribed solution against standard solution with known amounts of impurities.

Question 35

What information does pharmaceutical analysis provide?

Answer 35

Drug ID & purity 
Stability
Shelf-life
% content of drug
excipient ID
impurities ID and concentration
If the formulation meets certain specification