MOD 6: QC/QA - 2

Proverbs 16:3

Erweka

[Hardness Tester] Suspended Weights

Pfizer

[Hardness Tester] Pliers

Schleuniger

[Hardness Tester] Mootrized Anvil

Stokes-Monsanto

[Hardness Tester] Barrrel with Compressible Spring

Strong-Cobb

[Hardness Tester] Air Pump / hydraulic Pressure

2-3 kg

Hardness of Chewable and Sublingual Tablets

4-10 kg

Hardness of Ordinary Coated Tablets

7-10 kg (8-10 kg)

Hardness of Buccal Tablets

>10 kg

Hardness of Modified Release

<130 mg

[Weight Variation] Average Weight for ±10% Criteria

130-324 mg

[Weight Variation] Average Weight for ±7.5% Criteria

>324 mg

[Weight Variation] Average Weight for ±5% Criteria

4 Hours

[Disintegration Test] Disintegration Time for Buccal Tablets

30 minutes

[Disintegration Test] Disintegration Time for Plain, Uncoated Tablets

2-3 minutes

[Disintegration Test] Disintegration Time for Sublingual Tablets

37±2 deg C

[Disintegration Test] Temperature of Media

Initial Test = 6 Tablets. If all tablets disintegrate = PASS, if 1-2 Tablets did fail = Final Test --- Final Test = add another 12 Tablets. Final Criteria = NLT 16 Tablets should disintegrate out of 18.

Briefly explain the Disintegration Test Process

85-115%

Criteria for Content Uniformity Test (Percent Range)

Initial = 10 tablets; Retest = Add 20 Tablets (all in all, initial + retest = 30 tablets)

Number of Tablets for INITIAL and RETEST procedure of Content Uniformity Test

20 Tablets

Number of tablets for Weight Variation Test

10 Tablets

Number of tablets for Friability Test, if tablets have weights of >650 mg

There should be enough tablets equal to 6.5 g total mass

Number of tablets for Friability Test, if tablets have weights of less than or equal to 650 mg

Stage 1 = 6; Stage 2 = 6; Stage 3 = 12; Total = 24 Tablets

Number of Tablets for Dissolution Test

Initial = 10 Samples; Retest = 20 Samples; Total = 30 Samples

Number of Samples for Minimum Fill test

Chromophore

Functinal group that absorbs Radiant energy

Auxochrome

Functional group that does not absorb radiant energy but can enhance absorption of chromophore