Module 3 - Strategic case studies in practice

WRAFT(.?N LABORATOR E S CERTIFICATE OF ANALYSIS

PRODUCT:

COLD RELIEF CAPSULES

BATCH NQ:

005

Test

Results

Specification

APPEARANCE

SATISFACTORY

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

ODOUR

ESSENTIALLY ODOURLESS.

SATISFACTORY

UNIFORMITY OF WEIGHT (mg/ cap.)

350 331 340 343 354 344 355 346

337 350 356 347 340 342 344

340 346 350 348 351 346

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

332

362

3.87 4. 18 4.98 5.22 4.71

4.28 5.70

30 MAxiMUM

PRESENT

SATISFACTORY

CAFFEINE I.D.

PRESENT

SATISFACTORY

PHENYLEPHRINE I.D.

PRESENT

SATISFACTORY

PARACETAMOL (mg/cap.)

285

315

297

26.25

CAFFEINE (mg/cap.)

24.83

23.75

4.75

5.25

PHENYLEPHRINE HCl (mg/cap.)

4.87

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

5.44 4.54 4.39

4.38 4.48 4.81

4.35 4.27 4.45 5.44 4.66

AVERAGE = 5.75 .........• ~~··· .... ___________________o-'WEBB___BB_c_EhD_C_Ghem__MRS_C______ Chief Analyst 4.25

14.02.94

Teleph~El: &ih 8i5Sl'5 ·Fax: 0271 '81'5372 • • • • • • • • •

Wrafton Laboratories Ltd Wrafton Braunton North Devon EX33 2DL England

REGISTERED IN ENGLAND No. 2638733 REG. OFFICE: WRt\FTON LABORATORIES LTD WRAFTON BRAUNTON N. DEVON EXJJ 2DL