Module 3 - Strategic case studies in practice

WRAFT(.?N LAB 0 R ,~T 0 R E S CERTIFICATE OF ANALYSIS

PRODUCT:

COLD RELIEF CAPSULES

BATCH NQ:

001

Test

Results

Specification

APPEARANCE

SATISFACTORY

GREEN CAP, YELLOW BODY, SIZE 1 1 I CAPSULE.

()

ODOUR

ESSENTIALLY ODOURLESS.

SATISFACTORY

UNIFORMITY OF \-JEIGHT (mg/ cap.)

342 331 342 342 342 346 343 342

343 341 343 343 343 341 340

331 341 341 348 343 344

AVERAGE = DISINTEGRATION TIME (min.)

362

332

3.72 5.40 5.45 2.92 4.92 4.65 4.36

AVERAGE =

30 MAXIMUM

PARACETAMOL I.D.

PRESENT

SATISFACTORY

PRESENT

CAFFEINE I.D.

SATISFACTORY

(_)

PHENYLEPHRINE I.D.

SATISFACTORY

PRESENT

PARACETAMOL (mg/cap.)

315

308

285

CAFFEINE (mg/cap.)

24.47

23.75

26.25

5.25

PHENYLEPHRINE HCl (mg/cap.)

5.02

4.75

PHENYLEPH.UNI,. of CON. (mg/cap).

4.90 5. 14 4.60 5.63 4. 94

5.40· 4.52 5.44 4.58 4.71 4.51

AVERAGE =

4.25 5.75 .......... ~~ ...... . ------B-WB-B-B-B-8e-P-hD-GG-hem-MRSo--------:– Chief Analyst

14.02.94

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Wrafton Laboratories Ltd Wrafton Braunton North Devon EX33 2DL England

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