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Ph. Eur. Monograph 1075: Budesonide Related
Substances and Epimer A
In this application note we demonstrate the effective identification and
separation of Budesonide from its related substances following Ph.Eur .
Monograph 2232. To meet system suitability requirements for Related
S ubstances Assay, the peak to valley ratio must be a minimum of 2.5
between the first peak due to Impurity G and Budesonide Epimer A f or
reference solution (b). The peak to valley ratio is defined as Hp/ Hv ,
where Hp = height above the baseline of first peak due to Impurity G
and Hv = height above the baseline of the lowest point of the
curve separating this peak from the peak due to Budesonide Epimer A.
Also, the peak to valley ratio must be a minimum of 3 between the peak
due to Impurity L and Budesonide Epimer B f or reference solution (b).
The peak to valley ratio is defined as Hp/ Hv , where Hp = height above the
baseline of the peak due to Impurity L and Hv = height above the baseline
of the lowest point of the curve separating this peak from the peak due to
Budesonide Epimer B.
Ph. Eur. Monograph 1075: Budesonide Related Substances and Epimer A
In this application note we demonstrate the effective identification and
separation of Budesonide from its related substances following Ph.Eur .
Monograph 2232. To meet system suitability requirements for Related
S ubstances Assay, the peak to valley ratio must be a minimum of 2.5
between the first peak due to Impurity G and Budesonide Epimer A f or
reference solution (b). The peak to valley ratio is defined as Hp/ Hv ,
where Hp = height above the baseline of first peak due to Impurity G
and Hv = height above the baseline of the lowest point of the
curve separating this peak from the peak due to Budesonide Epimer A.
Also, the peak to valley ratio must be a minimum of 3 between the peak
due to Impurity L and Budesonide Epimer B f or reference solution (b).
The peak to valley ratio is defined as Hp/ Hv , where Hp = height above the
baseline of the peak due to Impurity L and Hv = height above the baseline
of the lowest point of the curve separating this peak from the peak due to
Budesonide Epimer B.
Document Type:
Technical Notes
Target Industries:
Techniques:
Brands:
Separation Modes:
Reversed Phase
Phases:
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