FINISHED PRODUCT QUALITY

CONTROL
SOLIDS
 TABLETS CAPSULES

• FRIABILITY TEST • DISINTEGRATION TEST

• DISINTEGRATION TEST • DISSOLUTION TEST
• DISSOLUTION TEST • UNIFORMITY OF DOSAGE UNITS
• UNIFORMITY OF DOSAGE UNITS
 FRIABILTY TEST

• MEASURE OF COMPRESSED UNCOATED TABLETS ABILITY TO WITHSTAND MECHANICAL

SHOCKS
• NOT FOR CHEWABLE TABLETS, SUBLINGUAL TABLETS
• APPARATUS: ROCHE FRIABILATOR
• SETTINGS: 25RPM FOR 4MINS (100 REVOLUTIONS)
• SAMPLE SIZE:
 IF AVERAGE TABLET WEIGHT <=650MG:WEIGH UNTIL 6.5G (13TABS)
 IF AVERAGE TABLET WEIGHT >650MG : 10UNITS

• ACCEPTANCE CRITERIA:
 NO CAPPING, CRACKING, CHIPPING, OR OBVIOUS TABLET BREAKAGE
 COMPUTE FOR %FRIABILITY
%FRIABILITY=INITIAL WEIGHT – FINAL WEIGHT NMT 1.0%
NMT 0.8%
FINAL WEIGHT X100
 DISINTEGRATION TEST

• APPARATUS: BASKET-RACK ASSEMBLY • CYCLES: 29-32 CYCLES/MINUTE

• MEDIUM: WATER • MEDIA TEMPERATURE: 37 +_2
• SAMPLE SIZE:
 INITIAL: 6UNITS
 RETEST: +12UNITS

• ACCEPTANCE CRITERIA:
 ANY RESIDURE OF THE UNIT IS A SOFT MASS HAVING A NO PALPABLE FOR
CORE
 RETEST IF 1 OR 2 FAILED TO DISINTEGRATE
o NMT2 OF THE 18 UNITS FAIL TO DISINTEGRATE
 DISINTEGRATION TEST

• USUAL DISINTEGRATION TIME

 IMMEDIATE RELEASE :30MINUTES
 BUCCAL RELEASE :4HOURS
 SUBLINGUAL TABLETES :2-3 MINUTES
 ENTERIC-COATED TABLETS
 5MINUTES IN WATER
 1HOUR IN SIMULATED GASTRIC FLUID T.S.
 SIMULATED INTESTINAL FLUID T.S.
 DISSOLUTION TEST

• RATE AND EXTENT OF ABSORPTION

 DISSOLUTION TEST

• APPARATUS • MEDIA TEMPERATURE : 37 ± 0.5C

 TYPE I - BASKET • SAMPLE SIZE
 TYPE II – PADDLE  INITIAL TEST = 6UNITS
 TYPE III – RECIPROCATING CYLINDER  1ST RETEST = +6 UNITS
 TYPE IV – FLOW THROUGH CELL  2ND RETEST = +12 UNITS
 TYPE V – PADDLE OVER DISK
 TYPE VI – REVOVLING CYLINDER
 TYPE VII – RECIPROCATING HOLDER
 DISSOLUTION TEST

• BASED ON Q (AMOUNT OF API RELEASES [%LC])

Stages Samples Acceptance

S1 6 Each unit is NLT Q +5%
S2 12 Average is >Q AND
No unit is <Q -15%
S3 24 Average is >Q
NMT 2 are <Q -15%
No unit is < Q -25%
 UNIFORMITY OF DOSAGE UNITS

• ENSURES THAT EACH TABLET WILL MEET THE SPECIFICATION FOR POTENCY
• ASSAY: AVERAGE POTENCY OF THE WHOLE BATCH
• METHODS
 WEIGHT VARIATION- FOR TABLETS WITH THE API AS MAJOR PORTION (>25MG)
 CONTENT UNFORMITY- ASSAY 10 DOSAGE UNITS INDIVIDUALLY (<25MG)
- %LC: 85-115%