Medicine: BP&Pharmaceutical Analysis Flashcards

1
Q

Name 4 sources of impurities

A

Raw materials, manufacturing method, decomposition, environment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Name the 10 important characteristics to check regarding making drugs

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

The pharmacopoeias and compendia are under which bit of law?

A

Human Medicines Regulations (HMR) 2012

Part 15

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

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

A

official (British or European) medicinal products and pharmaceutical substances

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

The European/British Pharmacopoeia defines requirements for…

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What substances does the European/British Pharmacopoeia cover?

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Name 3 Pharmacopoeias

A
European Pharmacopoeia (EP) 
British Pharmacopoeia (BP)
British Pharmacopoeia (Veterinary) - published as companion volumes to BP
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

The European Pharmacopoeia is under the direction of…

A

Council of Europe

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

The British Pharmacopoeia is under the direction of..

A

British Pharmacopoeia Commission Secretariat of MHRA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

The British Pharmacopoeia is the only offical source of…

A

British pharmaceutical standards

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

British Pharmacopoeia comprises of….what 2 things?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Which takes precedence, European Pharmacopoeia or British Pharmacopoeia?

A

European

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

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

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Name the specified publications under HMRs 2012

A
  • European Pharmacopoeia
  • British Pharmacopoeia
  • Cumulative List of Recommended International Non-proprietary Names (INN)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

INN=

A

BP+EP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

MHRA=

A

Medicines and Healthcare products Regulatory Agency

17
Q

BP originated in what year?

A

1864

18
Q

What is in a BP Monograph? (7)

A

-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

19
Q

Describe solubility statements in..

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

A

1) Just a guideline and not official requirement

2) official requirement

20
Q

Identification tests.. are hey absolute proof or not?

A

Not

21
Q

Visual comparative tests take place in?

A

Identical tubes with a flat base

Nessler cylinder

22
Q

Rules for BP Assays?

A

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

23
Q

Weighing needs to be to what accuracy?

A

+/- 5 units after the last figure

24
Q

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

A

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

25
Q

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

A

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

26
Q

Loss on drying reflects what?

A

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

27
Q

What does drying to a constant mass imply?

A

+/- 0.5mg difference in weight between two dryings

28
Q

What is a limit test?

A

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

29
Q

Give an example of a limit test

A

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