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Post: Interpretation of Monographs (Topic#4273)

prasad
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Posts: 2

02-05-09 01:05 AM - Post#5512

Hi,
I am prasad working with Pharma industry (Regulatory Affairs).
i need some clarifications regarding lnterpretation of monograph limits for related compounds/impurities.

Ramipril monograph USP31 NF26 indicates limits for Related compounds as follows
Not more than 0.5% of ramipril related compound A, ramipril related compound B, ramipril related compound C, or ramipril related compound D is found; not more than 0.1% of any other individual impurity is found; and not more than 1.0% of total impurities is found
------------------------- ------------------------- could u pl confirm the following.
1.Each related compound limit to be considered for Total impurities or not? if so sum of known impurities [0.5%*4 =2.0%] it self crossing total impurities limit of NMT 1.0%.

2. Is there any indication in monographs for not considering known impurities under total impurities.

looking for the response

have a nice day

regards
prasad