three analytical columns from specified lots validation kit 1: consists of two columns from one lot and one column from a second lot validation kit 2: consists of three columns from three different lots for documentation of robustness and reproducibility

YMC validation kits support your efforts to confirm the reliability of your chromatography methods. They enable you to assess the robustness of your method and to document the consistency of your results. Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) demand that analytical methods be reproducible over time and when moved from lab-to-lab or instrument-to-instrument. A first step in validation is confirming that your method provides reliable results when transferred from column to column.

Due to different approaches to validation, YMC alternatively offers two different validation column kits: Validation kit 1 contains two columns from a single bonding lot and one column from a different bonding lot. Each column comes with its own test chromatogram. The two matched columns are used to confirm that characteristics unique to a single column - artefacts of the column packing process, for example - are not affecting your results. The third column is used to assess whether lot-to-lot variations of a bonded phase affect your method. This is a test of the robustness of the method and provides assurance that the method will give reliable results over the life of your product.  Validation kit 2 contains three analytical columns packed with stationary phases from three different lots, in order to solely test the robustness of the particular method.

Other Validation Service

Occasionally, a critical analytical method will not prove as robust as you would prefer. Columns from a particular media lot may be the only way that you can, for example, isolate a critical process impurity. 
In such cases, YMC will reserve a specific lot of material for the use of an individual customer. We will also reserve prepacked columns for release according to a pre-arranged schedule. Call YMC or speak with your YMC representative for details. 

Ordering Information

Validation kit 1 (consists of two columns from one lot and one column from a second lot):
To order a validation kit 1 simply use the ordering number for the column of interest, e.g. OS 12 S05 1503 (where OS represents the selectivity here YMC-Pack Pro C8, 12 the porosity here 12 nm, S05 the particle size here 5 µm spherical and 1503 the column dimensions here 150 mm length and 3.0 mm i.d.) and add V1: OS12S051503V1. For details on YMC selectivities and the International Product Code please click here.

Validation kit 2 (consists of three columns from three different lots):
To order a validation kit 2 simply use the ordering number for the column of interest, e.g. AS 12 S03 1546 (where AS represents the selectivity here YMC-Pack Pro C18, 12 the porosity here 12 nm, S03 the particle size here 3 µm spherical and 1546 the column dimensions here 150 mm length and 4.6 mm i.d.) and add V2: AS12S031546V2. For details on YMC selectivities and the International Product Code please click here.