Que 1: What is the recommended temperature for checking DT of a dispersible tablet?
Ans: 25 ±10C (IP) & 15 – 250C (BP)
Que 2: What is mesh aperture of DT apparatus ?
Ans: 1.8 -2.2mm (#10)
Que 3: List out the appearance defects of tables during compression activity ?
Ans:
Capping:- ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.
Lamination / Laminating:- Definition: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers.
Sticking/filming: ‘ Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
Cracking:- Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.
Chipping:- ‘ Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
Mottling:‘ Mottling’ is the term used to describe an unequal distribution of colour on a tablet.
Double Impression: ‘ Double impression’ involves only those punches,which have a monogram or other engraving on them.
Que 4: What is the pass/fail criteria for disintegration test?
Ans: If one or two tablets/capsules fails to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is meet if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.
Que 5: What is the recommended storage conditions for empty hard gelatin capsules?
Ans: 15 – 250C& 35 -55% RH
Que 6: Which method is employed for checking “Uniformity of dosage unit”?
Ans: A.)Content uniformity
B.) Weight Variation
Weight variation is applicable for following dosage forms;
Hard gelatin capsules,uncoated or film coated tablets,containing 25mg or more of a drug substance comprising 25% or more by weight of dosage unit.
Que 6: What is the recommended upward and downward movement frequency of a basket-rack assembly in a DT apparatus?
Ans: 28 – 32 cycles per minute.
Que 7: When performing the ‘uniformity of weight’ of the dosage unit, how many tablet/capsule can deviate the established limit?
Ans: Not more than two of the individual weights can deviates from the average weight by more than the percentage given in the pharmacopeia,and none can deviates more than twice that percentage
Weight Variation limits for Tablets
| IP/BP | Limit | USP |
| 80 mg or less | ±10% | 130mg or less |
| More than 80mg or Less than 250mg | ±7.5% | 130mg to 324mg |
| 250mg or more | ±5% | More than 324mg |
Weight Variation limits for Capsules
| IP | Limit |
| Less than 300mg | ±10% |
| 300mg or More | ±7.5% |
Que 8:What needs to be checked during inprocess QA checks?
Ans:
a.) Environmental Monitoring
b.) Measured values obtained from the process equipment (ex:temperature,RPM etc.)
c.) Measured values obtained from persons (ex:timmings,entries etc.) d.) Process attributes (Ex:weight,hardness,friability etc.)
Que 9: What precautions shall be taken while collecting inprocess samples ?
Ans: While collecting inprocess samples, avoidcontamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken..
Que 10: If sticking observed during tablet compression what may the probable reason for the same?
Ans: 1.If the granules are not dried properly sticking can occur.
2.Too little or improper lubrication.
3.Too much binder
4.Hygroscopic granular
