Medicine: BP&Pharmaceutical Analysis

Question 1

Name 4 sources of impurities

Answer 1

Raw materials, manufacturing method, decomposition, environment

Question 2

Name the 10 important characteristics to check regarding making drugs

Answer 2

identity, purity, uniformity (monograph)
Potency, efficacy, toxicity,
Packaging, labelling, storing, stability

Question 3

The pharmacopoeias and compendia are under which bit of law?

Answer 3

Human Medicines Regulations (HMR) 2012

Part 15

Question 4

What does the Human Medicines Regulations (HMR) 2012 contain?

Answer 4

official (British or European) medicinal products and pharmaceutical substances

Question 5

The European/British Pharmacopoeia defines requirements for…

Answer 5

Qualitative and quantitative composition of medicines
and
Tests to be carried out of medicines and on substances and materials used in their production

Question 6

What substances does the European/British Pharmacopoeia cover?

Answer 6

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

Question 7

Name 3 Pharmacopoeias

Answer 7

European Pharmacopoeia (EP) 
British Pharmacopoeia (BP)
British Pharmacopoeia (Veterinary) - published as companion volumes to BP

Question 8

The European Pharmacopoeia is under the direction of…

Answer 8

Council of Europe

Question 9

The British Pharmacopoeia is under the direction of..

Answer 9

British Pharmacopoeia Commission Secretariat of MHRA

Question 10

The British Pharmacopoeia is the only offical source of…

Answer 10

British pharmaceutical standards

Question 11

British Pharmacopoeia comprises of….what 2 things?

Answer 11

1) Substances used in the practice of medicine (not veterinary)
2) Substances and articles used in the manufacture of (1)

Question 12

Which takes precedence, European Pharmacopoeia or British Pharmacopoeia?

Answer 12

European

Question 13

If a product is labelled BP, then it must conform with the standards specified in that monograph.
Name an offence(s) regarding this

Answer 13

to sell, supply or dispense a medicinal product of a particular name (if that name is at the head of a monograph in a pharmacopoeia) and the product does not comply with the standards specified in he monograph

Question 14

Name the specified publications under HMRs 2012

Answer 14

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

Question 15

INN=

Answer 15

BP+EP

Question 16

MHRA=

Answer 16

Medicines and Healthcare products Regulatory Agency

Question 17

BP originated in what year?

Answer 17

1864

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

Question 19

Describe solubility statements in..

1) Characteristics section
2) Under headings such as Solubility in ethanol

Answer 19

1) Just a guideline and not official requirement

2) official requirement

Question 20

Identification tests.. are hey absolute proof or not?

Answer 20

Not

Question 21

Visual comparative tests take place in?

Answer 21

Identical tubes with a flat base

Nessler cylinder

Question 22

Rules for BP Assays?

Answer 22

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

Question 23

Weighing needs to be to what accuracy?

Answer 23

+/- 5 units after the last figure

Question 24

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

Answer 24

If the figure after the decimal point is a zero or ends in a zero

Question 25

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

Answer 25

If the figure after the decimal point is NOT a zero or ends in a zero

Question 26

Loss on drying reflects what?

Answer 26

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

Question 27

What does drying to a constant mass imply?

Answer 27

+/- 0.5mg difference in weight between two dryings

Question 28

What is a limit test?

Answer 28

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

Question 29

Give an example of a limit test

Answer 29

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