Ipqc
Ipqc
TABLETS
IPQC Before, After & During The
Manufacturing
At Sampling Stage : Planning of sampling should be done
as per the Standard Operating Procedures (SOP)s which
describes the sampling methods. Sufficient quantity of
samples should be collected for Analysis.
At Manufacturing Stage : Weighing or measuring of active
pharmaceutical ingredients, excipients, diluents or vehicle
should be done under the suitable conditions which do not
affect their conformity of use. Appropriate and calibrated
equipment / instrument should be used for the above
purpose.
In Process Test Stage: In-process tests should be
performed on the sampled material. The quality control
dept. will be responsible for the testing. Samples are tested
by quality control personnel to verify conformance with
specifications within the acceptable limits.
Table: In-process Control Parameters
Official and Unofficial Tests for Evaluation of Tablets
Official Tests
1 Weight variation
2 Disintegration
3 Dissolution
4 Drug content
5 Friability
Non-Official Tests
1 Size and shape
2 Organo leptic
3 Thickness
5 Hardness
General Appearance:
-Organoleptic properties:
which include color, taste and odor of the tablets.
⦿ Thickness
can vary with no change in weight due to:
Tablet requires a certain amount of strength or hardness and resistance to friability to withstand mechanical shocks of
handling in manufacture, packaging and shipping. Hardness generally measures the tablet crushing strength.
Importance
To determine the need for pressure adjustments on the tableting machine.
Hardness can affect the disintegration.
So if the tablet is too hard, it may not disintegrate in the required period of time.
And if the tablet is too soft, it will not withstand the handling during subsequent processing such as coating or
packaging.
In general, if the tablet hardness is too high, we first check its disintegration before rejecting the batch.
If the disintegration is within limit, we accept the batch.
If Hardness is high + disintegration is within a time accept the batch.
Limits
5 kilograms minimum and 8 kilograms maximum.
Make hardness test on 5 tablets and then take the average hardness.
Friability
2. Friability
Friability of a tablet can determine in laboratory by Roche friabilator. This consist of a plastic chamber that revolves at 25 rpm,
dropping the tablets through a Distance of six inches in the friabilator, which is then operate for 100 revolutions. The tablets are
reweighed. Compress tablet that lose less than 0.5 to 1.0 % of the Tablet weigh are consider acceptable.
Weight variation test (uniformity of weight)
1. Weight variation test (uniformity of weight)
Weigh 20 tablet selected at random, each one individually. X1, X2, X3… Xz
IP STANDARDS
Sr. No Average wt. of tablet(mg) Max. % difference allowed
1 84 or Less 10%
2 84-250 7.5%
3 More than 250 5%
Content Uniformity Test
2. Content Uniformity Test
pass the test if 9 of the 10 tablets must contain not less than 85 % and not
and the 10th tablet may not contain less than 75 % and more than125 % of
It is the time required for the tablet to break into particles, the disintegration test is a
measure only of the time required under a given set of conditions for a group of tablets
Disintegration test is not performed for controlled & sustained release tablets.
According to the test the tablet must disintegrate and all particles must pass through the
10 mesh screen in the time specified. If any residue remains, it must have a soft
mass.
Disintegration Testing Conditions and Interpretation
U.S.P. method for uncoated tablets
Start the disintegration test on 6 tablets.
If one or two tablets from the 6 tablets fail disintegrate completely within 30 min
repeat the same test on another 12 tablet. (i.e. the whole test will consume 18 tablets).
Not less then 16 tablets disintegrate completely within the time
If more than two tablets (from the 18) fail to disintegrate, the batch must be rejected.
Procedure: The tablet was added into cylindrical vessel containing 1000 ml dissolution media having rpm 75 and tem.37±0.5˚C.
Dissolution of tablet was conducted 30 min, in 5 min. of interval, after 5 min 5 mL sample was removed and appropriate quantity
of sample take absorbance by using U.V. spectroscopy technique and determine rate of dissolution of tablet.
Procedure - The tablet was added into cylindrical vessel containing 1000 ml PH 1.2 Acidic media having rpm 75 for next two hours
and tem. 37±0.5˚C. Dissolution media was changes tablet was added in to PH 6.8 Phosphate buffer for next five hour for 1 hr. of
interval. After 1 hr. 5 mL sample was removed and appropriate quantity of sample take absorbance by using U.V. spectroscopy
technique and determine rate of dissolution of tablet.
Capsule
1. Dissolution apparatus – Type 2 (USP)
2. Temperature - 37±0.5˚C
3. Time – 5 hrs.
4. Media – PH 1.2 Acidic Buffer, PH 6.8 Phosphate buffer.
5. Rpm – 75 – 100.
6. Volume – 900 ml.
Procedure - The Capsule was added into cylindrical vessel containing 1000 ml PH 1.2 Acidic media having rpm 75 for next two hours and tem.
37±0.5˚C. Dissolution media was changes Capsule was added in to PH 6.8 Phosphate buffer for next three hour for 1 hr. of interval. After 1 hr. 5 mL
sample was removed and appropriate quantity of sample take absorbance by using U.V. spectroscopy technique and determine rate of dissolution of
Capsule.
Suppositories
5. Dissolution apparatus – Type 1 (USP)
6. Temperature - 37±0.5˚C
7. Time – 60 min
4. Time of interval – 10, 20, 30, 40, 50, 60.
5. Media – PH 7.4 Phosphate buffer.
6. Rpm – 50 – 75 rpm
7. Volume – 900 ml.
Procedure – The Suppository was added into cylindrical vessel containing 1000 ml dissolution media (PH 7.4 Phosphate buffer) having rpm 75 and
tem.37±0.5˚C. Dissolution of Suppository was conducted 60 min, in 10 min. of interval, after 10 min 5 ml sample was removed and appropriate
quantity of sample take absorbance by using U.V. spectroscopy technique and determine rate of dissolution of Suppositories.
Sr.no. Quantity Number of Acceptance criteria
Stage/level tablets tested
*D is the amount of dissolved active ingredient specified in the individual monograph, expressed as a
percentage of the labelled content.
** Percentages of the labelled content.
In Process Checks Shall Includes
Following Process Controls
Cleanliness of the area and line clearance
Checking of the status labels on the area and process containers.
Equipment/instrument: Calibration, verification and checking of the status labels.
Checking and verification of material used as Material Name, Material Code,
Control No. or A.R. No.
Time limits at all stages of process.
Checking of sieve/filter integrity.
Check vendor while goods are received and it should be according to approved
vendor.
Online review of batch record at every stage of process.
Product attributes Like Weight, Hardness.
Verification of yield at various stages of manufacturing process.
Periodic check of control samples.
Measured values obtained from the room environment like Temperature,
Humidity.