1. Related compoundsとChlorobenzeneが％→Area%に変更している。
これは、変更前に単なるAreaの記載漏れでしょうか？変更した理由した理由、いつ変更したか、品質への影響を教えてください。
2. Phenyl butyric anhydride :NMT 3.00 %についてCTDに明記されていないですが、実施しているのであればその書類を送付してください。
3. それ以外は変更なしという理解をしていますがよろしいですか?
Rating
52
Translation / English
- Posted at 28 Nov 2019 at 15:52
1. ％ of related compounds and Chlorobenzene are to change to % of area.
Was this just because of missing of description of area, right ? Just tell me the reason of change along with when to have changed, the influence to the quality.
2. Phenyl butyric anhydride :NMT 3.00 % isn't described at the CTD, but please send me a document if you are conducting.
3. Would it be alright that there is no changes rather than this?
Was this just because of missing of description of area, right ? Just tell me the reason of change along with when to have changed, the influence to the quality.
2. Phenyl butyric anhydride :NMT 3.00 % isn't described at the CTD, but please send me a document if you are conducting.
3. Would it be alright that there is no changes rather than this?
Rating
50
Translation / English
- Posted at 28 Nov 2019 at 15:52
1. Related compounds and Chlorobenzene were changed from percentage to areas percentage.
Is this that area was simply not filled out before change?
Please tell me the reason of the change, when it was changed and influence to quality.
2. Phenyl butyric anhydride: 3.00 percent was not listed in CTD.
If it has been carried out, would you send me a document?
3. May I understand that items other than that have not been changed?
Is this that area was simply not filled out before change?
Please tell me the reason of the change, when it was changed and influence to quality.
2. Phenyl butyric anhydride: 3.00 percent was not listed in CTD.
If it has been carried out, would you send me a document?
3. May I understand that items other than that have not been changed?
Rating
50
Translation / English
- Posted at 28 Nov 2019 at 15:50
1. Related compounds and Chlorobenzene are changed from ％→Area%.
Is this just missing note about AREA before changing?
Please tell me the reason of changing and when it was changed and the influence for quality.
2.About Phenyl butyric anhydride :NMT 3.00 %, it is not described in CTD.
If it has already executed, please send me document for it.
3.I understand that except for them are not changed, is it correct?
Is this just missing note about AREA before changing?
Please tell me the reason of changing and when it was changed and the influence for quality.
2.About Phenyl butyric anhydride :NMT 3.00 %, it is not described in CTD.
If it has already executed, please send me document for it.
3.I understand that except for them are not changed, is it correct?
