resource for column / system adequacy

[naili55]

Dear forum Members
I ld like to know if there is a reliable resource for columns and system adaptation
specifically,
columns: Lichrospher 100RP18 250mm and nucleosil 5C18 150mm on HPLC Shimadzu Prominence i-Series, Model LC-2030C

I could not find resources on merck neither on shimadzu website

the main reason is related to a method transfer from Waters HPLC Alliance to SHIMADZU Prominence

many thanks

[tom jupille]

We would need a bit more information as to what, exactly, you are trying to do:
Are you working in a regulated environment (subject to GCP or cGMP)?
Are you working with a compendial method (e.g, USP or EP), or is this an "in-house" validated method?

If it is an in-house method. and you are operating under GLP or cGMP, then your company should have SOPs ("Standard Operating Procedures") in place describing what you must do. If it's a compendial method, it should include system suitability criteria. In the simplest case, you run the method under the same conditions on the new system; if you pass system suitability, the system is suitable ( ).

If you don't pass system suitability, then the method will have to be modified and revalidated.

If what you are looking for is equivalent settings on the different data systems, then I can't help; you will have to learn both systems to find the corresponding settings.

If you are looking for column equivalencies, check the USP databases:
http://apps.usp.org/app/USPNF/columns.html

[naili55]

Thank you so much for this valuable site,
right, we are in cGMP environment and I m dealing with tech transfer, from a country A to a country B, where Waters is used in A while B will use Shimadzu
method is an in house validated, for final release of a drug

the aim of the question, is the similarity that we can get, in order to succeede in transfering the method, from A to B, without having to fully redo validation work ... at least, that what QC development guy told me... if the same columns are used, what ever the HPLC can be, we can have very simillar results,

(I m waiting confirmation from shimadzu that we can use on prominence
- Licrospher 100 RP 18, 25 cm long, internal diameter 4.0 mm, stainless steel
- Nucleosil 100 5C 18, 15 cm, internal diameter 4.6 mm, stainless steel

Question 2: is there a similar column equivalence resource for GC? we have to move from Agilent to shimadzu but couldnt find any
as I have to check shimadzu column equivalent to Agilent fused-silica capillary column 30 m long and 0.32 mm internal diameter, film thickness 1.8 μm (Chrompack CP select 624 CB

many thanks

[tom jupille]

Transfer between laboratories is actually part of validation (it comes under the heading of "reproducibility"). As a minimum you will have to meet system suitability at the new site, and then demonstrate that you are getting the same results on check samples at both sites. That said, if this is two sites from the same company, then you *should* have SOPs in place governing the transfer procedure.

As far as GC goes, there is much less variability than there is in LC columns. Match the dimensions, film thickness, and liquid phase chemistry and you should be OK. If this were my problem, I would simply use the Agilent columns in both instruments.

Columns are cheap, your time is valuable!

[chuong08h2a.vn]

nucleosil : u can find in Machery Nagel
Lichrospher : Knauer
i thouht that.

[naili55]

hi
thank you very much for your help!