how to do a validation for the ovi which is being done by gc hs as usp methods are quite tough and inhouse methods gives good results but how to do the validation of all this methods is there any web site is there which can \give detail how to proceed for the validation
By chris knutsen on Tuesday, July 31, 2001 - 05:19 am:
At a minimum you should check the USP chapter on Method Validations . There is also an ICH guideline on Validation of Analytical Procedures. Actually, the USP Method IV using head space sampling is one of the easier methods in this chapter to perform. All of the components are easily detectable and are also well resolved.
By Anonymous on Wednesday, August 1, 2001 - 11:02 pm:
as method iv tells to prepare chloroform solution in water how is it possible and i need how to validate the gc hs methods. detail protocol
By chirs knutsen on Thursday, August 2, 2001 - 05:40 am:
The only way that this can be done is to prepare the solvents originally in methanol, or the specified solvent, and then do the final dilution into water. Chloroform is soluble in water at this level. If you have a means to weigh 1.2 mg, you could make up 1 liter of standard at a time, but I would doubt the accuracy of this method. Alternatively, you can purchase standards from a number of sources. I am most familiar with the standard that are sold by Restek. They have served me very well for many years.
Good Luck. Meanwhile, if you choose to validate a new method, be sure to pay close attention to the information that was provided in the earlier response.
By Anonymous on Thursday, August 2, 2001 - 06:44 am:
We usually prepare STD stock solutions in high b.p. solvents such as DMF. Samples are injected by head space and most of DMF is left behind. If low b.p. solvent is used, there are greater possibilities that there are more low b.p. impurities in them and the method might be less rugged.
By Anonymous on Thursday, August 2, 2001 - 09:17 am:
We have used both methanol and dimethylsulfoxide and have nothad problems in our lab, but DMF sounds reasonable.
By Anonymous on Sunday, August 5, 2001 - 10:28 pm:
i want validation protocol for ovi can i get it ready made from any web site
By Anonymous on Monday, August 6, 2001 - 05:41 am:
Most companies have protocols that must be followed to validate methods. There is no source out there to my knowledge that offers methods for validation that are generally accepted by all agencies and companies.
Talk to other people in your company that have validated methods, and work out a protocol based on what your employeer expects.
By Chris Knutsen on Monday, August 6, 2001 - 01:33 pm:
Look to chapter 1265 in the USP for information as to what is expected in a method validation, or as I previously said, the ICH guidelines. None of these will give you a protocol, but they will tell you what is expected (at a mminimum).
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