STRATHCLYDE INSTITUTE OF PHARMACY AND BIOMEDICAL SCIENCES

MP/MC414: Medicines Manufacture and Quality Control 1

Date: Monday 10th August 2015

Time: 9.30am 11.30am

Duration: 2 hours

INSTRUCTIONS
Answer FOUR questions
Each question has an equal mark weighting

Please answer each question on a separate booklet you must ensure that
your name and registration number are on each answer booklet.

PLEASE TURN OVER

MP/MC414: MMQC1

August 2015

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Question 1

A)

Sketch the 1H-NMR (proton) spectrum of the compound A (structure

below) indicating the number of distinct proton signals, multiplicity, coupling
constants and integral of peaks expected for this compound.
(40%)

B)

Sketch the 13C-NMR (proton) spectrum of compound A. How many

different 13C peaks would you expect in the carbon-NMR spectrum of the
compound and why?
(20%)

C)

The electron impact-MS spectrum of compound A shows peaks at 251 (1%

relative abundance), 209 (6%), 164 (9%), 58 (100%) and 43 (85%) mass
units in the Electron Impact-MS spectrum. Suggest possible ion fragments
for these peaks and comment on their likely stability.
(40%)

PLEASE TURN OVER

MP/MC414: MMQC1

August 2015

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Question 2

A)

Using appropriate diagrams, explain how naproxen interacts with both normal
and reverse-phase stationary phases.

naproxen
(70 %)
B)

Calculate the content of timolol maleate remaining in an eye drop formulation.

D3-timolol maleate was used as the internal standard and you are provided
with the following data:
Expiry date:

11/2020

British Pharmacopeia limit of content:

Stated content of timolol maleate in eye drop formulation:
Volume of eye drop formulation analysed:

98.5 101.0%
0.5 % w/v
2.0 mL

Amount of timolol maleate in standard solution:

0.01023g

Standard solution:

Peak area (D3-timolol maleate):

118510

Peak area (timolol maleate):

146363

Peak area (D3-timolol maleate):

145271

Peak area (timolol maleate):

117964

Sample solution:

(25%)

C)

Does the sample comply with the British Pharmacopeia limit of content and
would it be effective if used for treatment? Explain your answer.
(5%)

PLEASE TURN OVER

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August 2015

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Question 3
Pharmaceutical products may degrade on storage through either chemical or
physical instability. Using three examples of instability (at least one chemical and
one physical) illustrate the formulation methods that can be used to limit their
degradation and instability and the steps you, as a pharmacist, can undertake to
ensure the instability does not affect the final medical product.
(100 %)

Question 4
A)

Give a brief description of at least five parameters commonly investigated as

part of a preformulation study of a new pharmaceutical molecule intended for
administration in a tablet form.
(40%)

B)

Give a brief description of four approaches that can be used to increase the
aqueous solubility of a pharmaceutical compound.
(40%)

C)

The aqueous solubilities of oestradiol and oestradiol benzoate are given

below. Explain why the benzoate ester would be more effective than
oestradiol when administered topically in an aqueous cream formulation.
(20%)

Aqueous solubility / g ml-1

oestradiol

oestradiol benzoate

0.4

PLEASE TURN OVER

MP/MC414: MMQC1

August 2015

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Question 5
Define and differentiate the following:
a)

LOD and LOQ

(25%)

b)

Random Error and Systematic Error (provide an example for each)

(25%)

c)

Selective Method and Specific Method (provide examples)

(25%)

d)

Accuracy and Precision

(25%)

END OF PAPER
Class Coordinator: Dr Ruangelie Edrada-Ebel

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August 2015

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