Checklist For Do’s And Don’ts For Dissolution Analysis

Checklist for Do’s and Don’ts for Dissolution Analysis

Checklist for Do’s

Always check the availability of chemicals and required glassware for the analysis.
Before loading dissolution check the Calibration status of the instrument.
Always check the water level of the dissolution bath (without a bowl).
Check the clarity of the water bath.
Check the status of the Water change frequency.
Update the status board before starting the dissolution and make relevant logbook entries.
Always use high-purity chemicals for dissolution medium preparation.
Always use purified water for media preparation.
In the case of foam-forming chemicals (dissolution medium) always use warm water. For e.g. SLS, dissolved in a minimum amount of medium and then make up to the volume required.
Always use a nose mask, goggles, and hand gloves while preparing the dissolution media.
Always use a trolley for carrying bowls (Jars) and dissolution medium.
Always use clean and dry bowls (Jars) without any scratches.
Use amber-colored bowls for light-sensitive products and perform the analysis in subdued light.
Wash the dissolution bowls properly and give the final rinse with the dissolution medium.
Autosampler Dissolution Apparatus: Wash the Sampler filter first with methanol and then twice with water.
Autosampler Dissolution Apparatus: Before starting analysis give washing for sampling assembly at least 5 Mins with purified water.
Autosampler Dissolution Apparatus: Wash thoroughly sample collection vials with purified water and dry it.
Wash the dissolution bowls properly and give the final rinse with the dissolution medium.
Pour the dissolution media into the bowl slowly from the side walls of the dissolution bowl (Jar).
Ensure that the required temperature of the dissolution medium in the jar is achieved before starting the analysis by using calibrated probe or thermometer.
Attain the bowl temperature by using a suitable device.
Paddles and baskets used for dissolution should be in good condition.
Fix the paddle rod shaft properly as per the number mentioned on it.
In the case of the basket fix the basket to the rod with care by holding the upper ring.
Always use a specific type of sinker as per specification.
Set the instrument parameters properly as per specification. (e.g. RPM, Temp. Type of Apparatus. )
Before starting the dissolution as per the parameters, put the tablets or capsules into the bowl (By using a tablet dispenser plate) and for pellets add directly in the bowl, and start immediately.
Autosampler Dissolution Apparatus: Give at least 1-2 ml rinsing volume before collection of sample.
Wash the cannulas using 0.1% Cleaning agent (Teepol) and then rinse them with purified water and dry it. Or as specified site SOP.
Adjust the cannula’s height according to the dissolution medium quantity by the holder. (Midway between the top level of the medium and the bottom of the paddle. And for the Basket mid-way between the top level of the medium and the end of the shaft)
Insert the cannulas in the bowls before 5 Mins of aliquot at specified time intervals in dissolution bowls.
While dissolution is running, monitor it timely at a certain time period. If an unusual observation is found, then inform to section head.
Collect the dissolution aliquots within 2% of the specific time interval as mentioned in the specification. (Immediately after finishing of dissolution)
Use the specific type of filter as mentioned in the specification.
During filtration of aliquots discard the first 2 to 3 ml and then collect it into a clean and dry test tube.
Apply constant pressure for the filtration of aliquots on a syringe or filter.
Use the single filter for all aliquots filtration.
For Dissolution Profiling use a single filter for Specific time intervals for all aliquots filtration.
Use a clean and dry test tube and a syringe for aliquots.
Label the test tubes/vials in which aliquots are collected having appropriate information, such as No. / A. R. No., Time interval, etc.
All waste syringes and filters are to be put into the waste bin after the completion of the analysis (Dissolution).
After completion of Dissolution, decant the medium in a bucket from the individual bowl (Jar) and dispose of it in the washing area.
Wash and dry individual bowls (Jars) and keep them in their respective position.
Wash and dry individual paddles/baskets/cannulas and keep them in the designated place.
Update the status board as no activity after the completion of the Dissolution analysis.

Checklist for Don’ts

Do not start the analysis if the required chemicals and glassware for the analysis are not available.
Do not use the instrument if it is not Calibrated.
If the water level is not up to the mark does not start the dissolution.
If the water is turbid in the water bath do not start the dissolution.
Do not start the analysis if the status of the Water change is not updated. Change the water and then start dissolution.
Do not start the analysis without updating the status board and making relevant logbook entries.
Do not compromise on the quality of the chemicals.
Do not use normal water (Tap water)
Avoid direct addition of the foam-forming chemicals (dissolution medium) into the required volume.
Avoid direct contact with skin and inhalation of the chemicals used for dissolution media, as they may be hazardous to health.
Do not carry it in your hands.
Do not use uncleaned and cracked bowls (Jars).
Do not use transparent bowls for light sensitive Products
Do not use the bowls without washing and rinsing.
Don’t start the analysis without washing the Sampler filter.
Don’t start the analysis without washing the sampling assembly.
Don’t use uncleaned vials.
Do not use the bowls without washing and rinsing.
Do not pour the dissolution media directly into the bowel as it forms the foam (e.g. If the media is SLS) or aeration.
Do not start the dissolution without checking the dissolution medium temperature.
Do not attain the bowl temperature by rotating the paddles in the media, it may cause aeration.
Do not use the damaged basket or damaged shafts for analysis.
Do not fix the paddles without checking numbers and loosely.
Never touch the Basket sieve or try to fix the basket by holding the sieve.
Do not use any type of sinker for dissolution.
Do not set parameters without reading specifications.
Do not put the tablets or capsules or pellets in the bowls when paddles or baskets are rotating.
Do not keep the rinsing volume to zero.
Do not use cannulas without washing and drying.
Do not insert cannulas without adjusting the position.
Do not insert the cannulas after starting the dissolution.
Do not continue the dissolution if any unusual observation is found. (e.g. Undissolved tablets, floating of capsules, sticking of tablet or capsule at the bottom of the bowl, etc.)
Do not collect aliquots after a long time.
Do not use any type of filter.
Do not filter aliquots directly into the test tube or vial without filter saturation.
Do not filter aliquots forcefully.
Do not use a separate filter for each aliquot.
Do not use the same filter for all the specified time intervals.
Do not use an uncleaned, wet test tube and syringe for dissolution.
Do not use glassware without labeling.
Do not put it into the wash basins or drawers after analysis (Dissolution).
Do not carry bowls (Jars) directly to the washing area.
Do not keep bowls (Jars) without washing them.
Do not keep the paddle/basket/cannulas without washing or on the Dissolution apparatus.
Do not keep the Status board as it is after the completion of the Dissolution analysis.