Module 3 - Strategic case studies in practice

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Subject: COLD RELIEF CAPSULES, FORMULA NQ:

WL001

Packaging: Blisters

Date: 10.05.93

BATCH NQ: A001

I P A R A ME T E R

T E N T A T I V E R E L E A S E SPECIFICATION

INITIAL RESULTS

Three Months

Six Months

Eleven Months

24 36 Months I Months

n·c

11 ·c

11 ·c

37·c

25•c

25"C

25•c

37·c

25•c

31·c

25°C'

Appearanc;:e

Green capped yellow bodied capsule containing a white

<------~' A T T 1 -----> <------~'A T T 1 -----> <------~' A T I 1 ----->

I Satis

flowing powder.

Odour

Essentially odourless. No foreign odour should be present. Must comply with the requirements of BP for Hard capsules.

I Complies

<--- C Q MP L IoE S -->

<--- C Q MP L IoE S --> I <--- C Q MP L IoE S -->

Uniformity of Weight

Complies

Average Net Weight (g) I 0.332 - 0.362

0.347

0.347

0.348

0.346

0.348

0.346

0.344 3.}, 3-k, 3-i, 3 ' 3 ' 6!.

0.343

0.348

0.346

Disintegration (mins)

Must comply with the requirements of BP for Hard Capsules.

3-k, 3-i, 3 ' 4, 4-k, 4t.

3;l-, 3t, 3 ' 4, 4, 4

3;}, 3-k, 3-i, 3-i, 3 ' 4.

3-k, 3;}, 3-i, 3-i, 4, 4.

3~, 3, 4, 4, 4;}, 4i}.

3, 3;}, 3-k, 3 J 3 ' 4.

3;}, 3 , 4, 4-k, 4!, 5i.

2 ' 3, 3;}, 3-i, 3!, 4.

2 ' 3, 3 ' 3-;}, 3-i, 4;}.

Identities

Paracetamol Caffeine Phenylephrine HCl

Positive Positive Positive

+ve +ve +ve

Uniformity of Content of Phenylephrine HCl

Must comply with the requirements of BP for capsules.

Complies

Paracetamol (mg/cap)

285 - 315

296

291

301

300

296

296

294

292

295

296

Caffeine (mg/cap)

23.75 - 26.25

24.3

25.6

25.9

24.6

25.7

24.0

24.0

24.7

24.9

25.3

Phenylephrine HCl (mg/cap)

4.75 - 5.25

4.74

4.63 4.66 <--- C l MP L IjE S --> 4.54

5.15 4.97 <--- c l M p L IIE s --> 4.83

4.98 4.92 <--- c l Mp L IIE s --> 4.92

Not.more than 0.005% of the paracetamol content.

4-Aminophenol

Complies

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N HAMMETT

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