Process for Determining the Suitability for Distribution of a Batch of Thiophene-2-Carboxamide Derivative

A process for determining the suitability for distribution of a batch of rivaroxaban (compound I), or a pharmaceutical composition comprising rivaroxaban, said process comprising:

• (a) producing a batch of rivaroxaban, or a pharmaceutical composition comprising rivaroxaban;
• (b) measuring in a sample of the batch or the pharmaceutical composition the concentration of N,N′-bis[{(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl]urea (Compound A)
• and/or the concentration of N,N′-bis[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl]benzene-1,2-diamide (Compound B) using, respectively, Compound A and/or Compound B as reference marker;
• and
• (c) validating the batch or the pharmaceutical composition for distribution only if the sample of the batch or the pharmaceutical composition is free or substantially free of Compound A and/or free or substantially free of Compound B.

A process for preparing a batch of rivaroxaban (compound I) for pharmaceutical use, or a pharmaceutical composition comprising rivaroxaban, said process comprising determining the suitability for distribution of the batch of rivaroxaban, or the pharmaceutical composition comprising rivaroxaban, by a process comprising:

• (a) producing a batch of rivaroxaban, or a pharmaceutical composition comprising rivaroxaban;
• (b) measuring in a sample of the batch or the pharmaceutical composition the concentration of N,N′-bis[{(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl]urea (Compound A) using Compound A as reference marker;
• and
• (c) validating the batch or the pharmaceutical composition for distribution only if the sample of the batch or the pharmaceutical composition is free or substantially free of Compound A.

A process for preparing a batch of rivaroxaban (compound I) for pharmaceutical use, or a pharmaceutical composition comprising rivaroxaban, said process comprising determining the suitability for distribution of the batch of rivaroxaban, or the pharmaceutical composition comprising rivaroxaban, by a process comprising:

• (a) producing a batch of rivaroxaban, or a pharmaceutical composition comprising rivaroxaban;
• (b) measuring in a sample of the batch or the pharmaceutical composition the concentration of N,N′-bis[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl]benzene-1,2-diamide (Compound B) using Compound B as a reference marker;
• and
• (c) validating the batch or the pharmaceutical composition for distribution only if the sample of the batch or the pharmaceutical composition is free or substantially free of Compound B.

A process for preparing a batch of rivaroxaban (compound I) for pharmaceutical use, or a pharmaceutical composition comprising rivaroxaban, said process comprising determining the suitability for distribution of the batch of rivaroxaban, or the pharmaceutical composition comprising rivaroxaban, by a process comprising:

• (a) producing a batch of rivaroxaban, or a pharmaceutical composition comprising rivaroxaban;
• (b) measuring in a sample of the batch or the pharmaceutical composition the concentration of N,N-bis[{(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl]urea (Compound A) and the concentration of N,N′-bis[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl]benzene-1,2-diamide (Compound B) using, respectively, Compound A and Compound B as reference markers;
• and
• (c) validating the batch or the pharmaceutical composition for distribution only if the sample of the batch or the pharmaceutical composition is free or substantially free of Compound A and free or substantially free of Compound B.