EP standards to validate Vista for compliance Follow
Question:
Our customer, CSL Limited in Australia, purchased our Vista instrument. Additionally, they bought the EP Color Standards from Sigma-Aldrich, as recommended in our HunterLab AN-1032 application note.
They expected to measure the standards seamlessly with our Vista.
However, the standards from Sigma-Aldrich came in round vial-ampoule form, and the Certificate of Analysis (CoA) specifies that these standards are for direct use and should not be opened.
As a result, they were unable to measure the standards using our Vista and the D02-1017-048 sample holder they purchased.
Answer:
To begin, the Sigma-Aldrich round vial-ampoule are sold as visual samples, that conform to EP 2.2.2 Method I, where 2mm of reference solution in a 12mm diameter vial are used to compare. They are designed to be unopened from their vials and kept in their packaging where the vials are ordered from lowest to highest value. The user can then easily place their sample in a similar vial to do the visual comparison. There are three approved methods for determination. 2mm solution in vial, 15mm-25mm diameter vial filled to produce a 40mm deep viewing column, instrumental determination using 1cm cuvette. Unfortunately, the suppliers of certified standards are currently only providing small volume vials. The customer will need to open the vials by either scoring and snapping the top or by using pliers to open the top. The liquid can then be transferred to a cuvette for measurement.
HunterLab AN-1032 specifically says it is for validating EP color using a HunterLab UltraScanPro or UltraScanVis. The sample holders and vials described in the AN are specific to the UltraScanPro and UltraScanVis and are not compatible with the Vista.
The customer can choose the container that best fits their needs, 2R, 4R, Macro cuvettes are the most used.
Please remember that prior to January 2021 the EP did not have an instrumental method, customers either made their own standards at volumes they required or purchased vials for Method I use. HunterLab uses the vials to validate our instruments, the volume of liquid in the vial is sufficient to fill a cuvette for measurement in the Vista.
Comments
0 comments
Please sign in to leave a comment.