FAQ
All
No. Class Title
  31   Drug Substance  

Is it suitable to use the USP<231>heavy metals methods to control all of the elemental impurities?

 
  32   Drug Substance  

If a drug substance may contain different numbers of solvated water (ex: anhydrous, hemihydrate, monohydrate or dihydrate forms), is it required to denote the numbers of solvated water in the name of the drug substance?

 
  33   Drug Substance  

How does one justify the suitability of a primary reference standard if the primary reference standard is not purchased from a pharmacopoeial or equivalent sources?

 
  34   Drug Substance  

When submitting a DMF or API registration application, if the specification of the drug substance is established based requirements listed in a compendial monograph, what should other requirements be noted?

 
  35   Drug Substance  

If an active pharmaceutical ingredient (API) has an amorphous crystal form, is it necessary to provide analysis results for its crystal form?

 
  36   Drug Substance  

If a drug substance is not included in monographing pharmacopeia, what are the requirements for the drug substance specification?

 
  37   Drug Substance  

According to the DMF technical information check list promulgated by TFDA, the drug substance process validation data may be replaced by the process validation protocol and a representative batch record. Is it required for the representative batch record to be from one of the process validation batches?

 
  38   Drug Substance  

What are the requirements for filing a DMF or API application where the drug substance is a mixture of two other drug substances?

 
  39   Drug Substance  

Is it required to submit separate DMFs for the same drug substance but with different grades of particle sizes (different particle size distributions) ?

 
  40   Drug Substance  

If the submitting drug substance with two or more crystalline hydrate formulas, should DMF divide into different applications? If a drug substance has different solvated forms (hydrates), is it required to file a separate DMF for each of the hydrate?

 
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