1. During related substances calculation, what are the criteria of RRF & RF, CCF, when included in the calculation & when not?
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The Relative Response Factor (RRF) represents the ratio of the detector responses of equal amounts of an impurity and the drug substance. In the United States Pharmacopoeia (USP), RRF is referred to as Response Factor (RF), or Relative Response Factor (RRF), and is denoted as F. In contrast, the European Pharmacopoeia (Ph. Eur.) refers to it as a Correction Factor (CF) or Calibrated Correction Factor (CCF), which is the reciprocal of the Relative Response Factor (i.e., CF or CCF = 1/RRF).
- RRF between 0.8 and 1.2 should be considered as 1.0 and may not be used for calculation.
- The RRF of less than 0.2 or more than 5 should not be included in the calculation.
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