| Username | Post: Interpretation of Monographs |
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prasad Beginner 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 |