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- Posts: 1
- Joined: Fri Jun 08, 2012 6:10 pm
I have posed this question to the USP but I'd like to get some Forum feedback:
I work for a contract testing lab and sometimes we are tasked with testing an API/raw material/finished product by 467 and the solvents that are likely to be present are known. In my example, lets assume the solvents likely to be present are a Class 1 and one Class 2, and the vendor is certified. My questions stem from this statement in 467, “When Class 1 residual solvents are used or produced in the manufacture or purification of a drug substance, excipient, or drug product and are not removed by the process, these solvents should be identified and quantified. The procedures described in the section Identification, Control, and Quantification of Residual Solvents in this general chapter are to be applied wherever possible.”
-What is meant by quantified for a Class 1 solvent? A quantitative numerical value following Procedure C or would it be justifiable to follow Procedure A to ensure the class 1 solvent (that we know is likely to be present) is below its limit ( ie its response is less than the response in the standard)? I realize the USP states you can just go to Procedure C if you know what solvents are likely to be present but we are hesitant to quantitate if its not really needed, especially if more than one solvent is present. At that point its quicker and easier to follow Procedure A/B. Also, verification is much easier and less troublesome when we verify per Proc A/B since we do not have to concern ourselves with Accuracy/Precision and sometimes Linearity studies.
I work for a contract testing lab and sometimes we are tasked with testing an API/raw material/finished product by 467 and the solvents that are likely to be present are known. In my example, lets assume the solvents likely to be present are a Class 1 and one Class 2, and the vendor is certified. My questions stem from this statement in 467, “When Class 1 residual solvents are used or produced in the manufacture or purification of a drug substance, excipient, or drug product and are not removed by the process, these solvents should be identified and quantified. The procedures described in the section Identification, Control, and Quantification of Residual Solvents in this general chapter are to be applied wherever possible.”
-What is meant by quantified for a Class 1 solvent? A quantitative numerical value following Procedure C or would it be justifiable to follow Procedure A to ensure the class 1 solvent (that we know is likely to be present) is below its limit ( ie its response is less than the response in the standard)? I realize the USP states you can just go to Procedure C if you know what solvents are likely to be present but we are hesitant to quantitate if its not really needed, especially if more than one solvent is present. At that point its quicker and easier to follow Procedure A/B. Also, verification is much easier and less troublesome when we verify per Proc A/B since we do not have to concern ourselves with Accuracy/Precision and sometimes Linearity studies.
