Module 3 - Strategic case studies in practice

WRAFT{.?N LAB ORATOR E S CERTIFICATE OF ANALYSIS

PRODUCT:

COLD RELIEF .CAPSULES

BATCH NQ:

003

Specification

Test

Results

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

APPEARANCE

SATISFACTORY

ESSENTIALLY ODOURLESS.

ODOUR

SATISFACTORY

UNIFORMITY OF WEIGHT (mg/cap.)

349 341 342 337 342 343

342 345 343 343 346 338 342 342

341 343 334 348 343 339 340

AVERAGE = DISINTEGRATION TIME (min.) AVERAGE =

362

332

3.52 3.37

5.03 2.98 2.62 4.28 3.63

30 MAXIMUM

PRESENT.

SATISFACTORY

PARACETAMOL I.D.

PRESENT

CAFFEINE I.D.

SATISFACTORY

(' \_j

PRESENT

PHENYLEPHRINE I.D.

SATISFACTORY

315

285

PARACETAMOL (mg/cap.)

310

26.25

23.75

CAFFEINE (mg/cap.)

24.84

5.25

4.75

4. 77

PHENYLEPHRINE HCl (mg/cap.)

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

4.78 5.03 5.31

5.01 4.78 4.94

4.83 5.25 4.47 5.08 4.95

AVERAGE = 5.75 ......... ~!// ....... . ------------------B-W-EBB-B.£&--RhD-CG.hem-M-R-£~or- ------; Chief Analyst 4.25

14.02.94

Wrafton Laboratories Ltd Wrafton Braunton North Devon EX33 2DL England

TelephonP.fu'l1f?s1581"5 ·Fax: 0271'8!5372 • • • • • • • • • •

RE(iiSTERED IN ENGLAND :-:o. 263l'li33 REG. OFFICE: WRAFTON LABORATORIES LTD WRAFI'ON BRAUNTON N. DEVON EXJJ 2DL