Module 3 - Strategic case studies in practice

WRAFT(.?N LABORATOR ES CERTIFICATE OF ANALYSIS

PRODUCT:

COLD RELIEF CAPSULES

BATCH NQ:

004

Test

Results

Specification

APPEARANCE

SATISFACTORY

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

SATISFACTORY

ODOUR

ESSENTIALLY ODOURLESS.

UNIFORMITY OF WEIGHT (mg/ cap.)

349 350 351 346 353 350 351 349

350 346 344 348 358 351 349

349 343 348 346 347 349

·AVERAGE = DISINTEGRATION TIME (min.) AVERAGE = PARACETAMOL I.D.

332

362

4.35 4.97 3.97 5.27 4.29

3.70 3.48

30 MAXIMUM

SATISFACTORY

PRESENT

CAFFEINE I.D.

PRESENT

SATISFACTORY

(~)

PHENYLEPHRINE I.D.

PRESENT

SATISFACTORY

315

285

PARACETAMOL (mg/cap.)

303

26.25

23.75

24.86

CAFFEINE (mg/cap.)

5.25

PHENYLEPHRINE HCl (mg/cap.)

4.93

4.75

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

5.37 5.05 4. 74 5.01 4.86

5.12 4.81 4.29

4.48 4.55 5.23

AVERAGE =

5.75 ....... ~J. ........ . B-W-E-B-B-B-Se-Fhil-GG-hem-M-R-SG Chief Analyst

4.25

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14.02.94

Teleph~t'l. 81-.5815 Fa:x:·DZ7l. 8153'72- • • • • • • • • •

Wrafton Laboratories Ltd Wrafton Braunton North Devon EX33 2DL England

REGISTERED IN ENGLAND No. :!63H733 REG. OFFICE: WRAFTON LABORATORIES LTD WRAFfON BRAUNTON N. DEVON EX33 :!DL