FAQ
Drugs
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No. Class Title
  1   Drug Substance  

If only Class 3 solvents are used in themanufacturing process of active pharmaceutical ingredient (API) and the loss on drying (LOD) test result is more than 0.5%, should the Class 3 residual solvents be controlled individually?

 
  2   Drug Substance  

Is it allowed to use a nonspecific method such as loss on drying to control residual solvents in the active pharmaceutical ingredient (API) when only Class 3 solvents are used in the API manufacturing process?

 
  3   Drug Substance  

If a solvent used in drug substance manufacturing process may be contaminated with ICH Q3C class 1 residual solvents (for example., toluene or acetone may contain benzene), what information should be provided if routine analysis of class 1 solvent in intermediates or in final drug substance is expected to be waived?

 
  4   Drug Substance  

What information should be included in the DMF/API application data for a starting material that is commercially available?

 
  5   Drug Substance  

The long- term stability studies (25 ± 2 °C/60± 5%RH ) and the accelerated stability conditions are (40 ± 2 °C/75± 5%RH ) are performed using three drug substance batches. If the stability result of one of three batches has a significant change during the stability testing period in the accelerated studies, what actions should be undertaken? (“Significant change” for a drug substance is defined as failure to meet its specification.)

 
  6   Drug Substance  

Should all analytical methods listed in a drug substance specification be fully validated?

 
  7   Drug Substance  

When submitting a DMF application, is it acceptable to submit only a batch manufacturing record and not performing the process validations using three industrial batches?

 
  8   Drug Substance  

What is the definition of an API mix? What information must be provided while submitting a DMF for API mix?

 
  9   Drug Substance  

If a potential genotoxic impurity is formed or introduced prior to the final step of the API manufacturing process, under what conditions can one waive routine control of the potential genotoxic impurity in the drug substance specification?

 
  10   Drug Substance  

If a new drug substance is not yet listed in any pharmacopoeial monograph, how does one establish the acceptance criterion for total (organic) impurities in the drug substance specification?

 
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