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Ans:For tablets with unit mass equal or less than 650 mg, take sample of whole tablets
corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole
tablets.
Q. What is the formula for calculating weight loss during friability test?
Ans: %Weight loss = Initial Weight - Final Weight X 100
Initial Weight
Q. What is the pass or fail criteria for friability test?
Ans: Generally the test is run for once.If any cracked,cleaved or broken tablets present in the
tablet sample after tumbling,the tablets fails the test.If the results are doubtful,or weight loss is
grater than the targeted value,the test should be repeated twice and the mean of the three tests
determined.A mean weight loss from the three samples of not more than 1.0% is considered
acceptable for most of the products.
Q. What is the fall height of the tablets in the friabilator during friability testing?
Ans: 6 inches.Tablets falls from 6 inches height in each turn within the apparatus.
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.
Q. What is the recommended storage conditions for empty hard gelatin capsules?
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.
Q. 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
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.)
Q. What precautions shall be taken while collecting in process samples ?
Ans: While collecting inprocess samples, avoid contamination of the product being sampled
(Don’t collect samples with bare hands) & avoid contamination of sample taken.
Q. 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
Q. What checks shall be carried out, while calibrating DT apparatus?
Ans: While calibrating DT apparatus, following checks shall be performed.
1.) Number of strokes per minute (Limit:29-32 cycles/min)
2.) Temperature by probe & standard thermometer
(Limit: 37 ± 1 OC).
3). Distance travelled by basket (Limit:53 -57mm)
Where as dissolution is a process by which solid substance enters in the solvent to yield a
solution.It is controlled by the affinity between the solid substance and the solvent.
Where as Validation is a documented program that provides high degree of assurance that a
specific process, method or system consistently produces a result meeting pre-determined
acceptance criteria.
Calibration ensures that instrument or measuring devices producing accurate results. Whereas
validation demonstrates that a process, equipment, method or system produces consistent results
(in other words, it ensures that uniforms batches are produced).
Q. Why do we consider three consecutive runs/batches for process validation? Why not
two or four?
Ans: The number of batches produced in the validation exercise should be sufficient to allow the
normal extent of variation and trends to be established and to provide sufficient data for
evaluation and reproducibility.
· First batch quality is accidental (co-incidental),
· Second batch quality is regular (accidental),
· Third batch quality is validation(conformation).
In 2 batch we cannot assure the reproducibility of data,4 batches can be taken but the time and
cost are involved.