Photo stability :
We check the stability of samples under environmental condition such as light(photo).
An artificial light similar to natural light will be exposed to the samples and check the quality before expore and after exposure will be monitored and justified.
The intrinsic photostability characteristics of new drug substances and products should be
evaluated to demonstrate that, as appropriate, light exposure does not result in
unacceptable change. Normally, photostability testing is carried out on a single batch
It happens in two ways.
1. Confirmatory studies
For confirmatory studies, samples should be exposed to light providing an overall
illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter to allow direct comparisons to be made between the drug substance and drug product.
2.Forced degradation(stress testing)
To provide the analytical method is stability indicating, the exposure will be very high than confirmaroty testing.
Sample analysis :
At the end of the exposure period, the samples should be examined for any changes in Quality.
Step :1 expose directly and analyse the sample, if sample passes its specification, no futher testing, study is completed.
If fails at step 1, expose on primary packing,if sample passes its specification, no futher testing, study is completed.
If fails at step 2, expose on sencondar packing,
If fails, change the packing style and study it once again.
Procedure for Light energy verification :Spread about 5 g of sample in a transparent Petri dish and expose to light for three times cycle to 1200 KLUX hours and 200 Watt-Hours / Sq.mts.Spread about 5 g of sample in a transparent Petri dish and expose to light for three times cycle to 1200 KLUX hours and 200 Watt-Hours / Sq.mts.
We check the stability of samples under environmental condition such as light(photo).
An artificial light similar to natural light will be exposed to the samples and check the quality before expore and after exposure will be monitored and justified.
The intrinsic photostability characteristics of new drug substances and products should be
evaluated to demonstrate that, as appropriate, light exposure does not result in
unacceptable change. Normally, photostability testing is carried out on a single batch
It happens in two ways.
1. Confirmatory studies
For confirmatory studies, samples should be exposed to light providing an overall
illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter to allow direct comparisons to be made between the drug substance and drug product.
2.Forced degradation(stress testing)
To provide the analytical method is stability indicating, the exposure will be very high than confirmaroty testing.
Sample analysis :
At the end of the exposure period, the samples should be examined for any changes in Quality.
Step :1 expose directly and analyse the sample, if sample passes its specification, no futher testing, study is completed.
If fails at step 1, expose on primary packing,if sample passes its specification, no futher testing, study is completed.
If fails at step 2, expose on sencondar packing,
If fails, change the packing style and study it once again.
Procedure for Light energy verification :Spread about 5 g of sample in a transparent Petri dish and expose to light for three times cycle to 1200 KLUX hours and 200 Watt-Hours / Sq.mts.Spread about 5 g of sample in a transparent Petri dish and expose to light for three times cycle to 1200 KLUX hours and 200 Watt-Hours / Sq.mts.
Note: If the degradation is more than 20% for 1200 KLUX hours and 200 Watt-Hours /Sq.mts three times cycle sample, perform the analysis on 1200 KLUX hours and 200 Watt-Hours / Sq.mts two times cycle sample.Establish the Actinometric system simultaneously for the corresponding sample, employing the procedure ICH Q1B Option –1.
Actinometric standard solution: Use 2% W/V Qunine monohydrochloride DihydrateAqueous solution. Option –1: Put 10 milliliters (mL) of the solution into a 20 mL colorless ampoule seal it hermetically(air tight), and use this as the sample. Separately, put 10 mL of the solution into a 20 ml
colourless ampoule, seal it hermitically, wrap in aluminum foil to protect completely from light, and use this as the control. Expose the sample and control to the light source for an appropriate number of hours. After exposure determine the absorbances of the sample (AT) and the control (Ao) at 400 nm using a 1 centimeter (cm) path length. Calculate the change inabsorbance,
∆ A = AT – AO.
Acceptance criteria: The length of exposure should be sufficient to ensure a change in absorbance of at least 0.9.
what is actinometry
ReplyDeleteParameters of validation prove the precision and stability of the method and it's applicability for the Assay of tadalafil and sildenafil citrate.
ReplyDeleteThe state of the art photo stability chambers are designed for quick and reliable photostability testing . The results of testing are quite dependable, or precisely accurate.
ReplyDelete