Module 3 - Strategic case studies in practice

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Subject: COLD RELIEF CAPSULES, FORMULA NQ:

WL001

Packaging: Blisters

Date: l0i.05.93

BATCH NQ:

A030

24 I 36

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

Months

Months

11 ·c

11 ·c

11 ·c

25"C

37"C

25"C

37"C

25"C

25"G

37"C

25"C

Appearance

Size 1 capsule containing a white flowing powder.

I <------~5 A T I 1 ----->

<------~5 A T I 1 ----->

<------~5 A T I 1 ----->

Satis

Odour

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

Complies I <--- C Q MP L I 1E S -->

<--- C Q MP L I1E S -->

<--- C Q M P·L IoE S -->

Uniformity of Weight

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Complies • -----

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Average ~et Weight (g) I 0.332 - 0.362

0.349

0.348

0.354

0.352 -

0.350

0.350

0.352

0.347

0.352

0.351

Disinteg~ation (mins)

Must comply with the requirements of BP for Hard Capsules.

3, 3,

2, 2-k, 2-k, 2 2 ' 3.

2-[, 2-4-, 2 ' 3, 3, 3-!r.

3;}, 3;}, 3-[, 3-[, 3 ' 4.

2-[, 3, 3-k, 3-k, 3-[, 3 .

2, 2-k, 2-k, 2-[,

2-k, 2-4-,

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

2-[, 2 , 2 ' 3, 3, 3-k.

2-4-, 2-4-, 2t, 3,

3-k, 3-[, 3 ' 3 .

2t, 2t, 2 ' 2 . 3, 3t. 3, 3.

1

Identities

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Paracetamol Caffeine Phenylephrine HCl

Positive Positive Positive

+ve +ve +ve

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Uniformity of Content of Phenylephrine HCl

Must comply with the requirements of BP for capsules.

Complies

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Paracetamol (mg/cap)

285 - 315

292

298

304

300

298

301

297

298

297

302

Caffeine: (mg/cap)

23.75 - 26.25

24.5

24.7

24.8

24.2

24.0

24.8

24.2

25.1

24.7

24.6

Phenylephrine HCl (mg/cap) ·

4.75 - 5.25

5.06

5.00

4.80

4.87

5.12

4.83

4.96

5.07

5.02

4.89

<--- C l MP L liES-->

C l M P L liE

s -->

E s -->

<---

4-Aminopljlenol

Not more than 0.005% of the paracetamol content.

<--- CrMPLI

Complies

1

rJ.H~

N HAMMETT