Qualification Information – MicroSolv Technology Corporation

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Can I use the UV Calibration Kit to qualify detection at 200nm? – FAQ

The caffeine standard provides two data points at 205 and 273nm. The holmium oxide solution covers 14 absorbance bands in the range of 241 – 641nm. Hence, you can obtain a calibration curve from these various data points and then extrapolate down to 200nm. This is the lowest you would need to go because of the UV […]

Can the HSQ or PQ kits be used with Waters equipment and Empower chromatography data software?

Yes, the MicroSolv HSQ™ and PQ™ kits can be used with any type of HPLC instrument or data system the instrument may have. However, note that Waters Associates™ offers a somewhat similar performance qualification kit to the MicroSolv kits that is designed to run automatically with and under Empower™, automating the entire process. The MicroSolv PQ kit […]

Can the L3 linearity solution supplied in the HSQ Kit be used for UV wavelength accuracy? – FAQ

The short answer is yes. Many other vendors use only caffeine for wavelength accuracy, at 205 and 273 nm. Holmium oxide of course covers 241-641nm, and is directly traceable to NIST standards. However, if you want, there is no reason you could not simply take the spectrum of caffeine. The L3 solution provides a nice, mid-range […]

Difficulties with wavelength accuracy readings for HPLC PQ – Blog

Evaluation of wavelength accuracy on older, less sensitive detectors can be a little difficult at times. Getting bubbles in the flow cell is a problem and we recommend that you pull the Wavelength Calibration solution through the flow cell, then disconnect the syringe, and allow the system to rest, and keep the inlet/outlet tubing ends above the flow cell […]

Does the UV-Vis Calibration Kit operate in all three ranges, UV, Vis and Vis/NIR? – FAQ

The UV kit only contains potassium dichromate for absorbance accuracy, holmium for wavelength accuracy and potassium iodide for stray light. It will not cover the other wavelength ranges and can be used to comply with USP <857> for the ranges where these are applicable. The chart below is provided for acceptable criteria in the USP <857> as Wavelength […]

How do I determine wavelength accuracy below 230nm for HPLC instruments?

Holmium Oxide is an internationally recognized wavelength calibration primary standard, supported by NIST and other standards organizations. It provides 14 official absorbance bands ranging from 241 nm to 641 nm. Caffeine is considered a secondary standard, with two absorbance bands at 205 nm and 273 nm. Caffeine is also widely used as a wavelength and […]

How do I validate the Excel spreadsheet that comes with the HSQ™ Kit?

There is no need for the end-user to perform any validation of HSQ Kit™ Excel spreadsheet. The document is fully validated by the factory. A certificate of validation can be provided upon request if needed (see below attached document). The scope of the validation encompasses the design of the spreadsheet, that its calculations are accurate and perform […]

How does a Pulse from an HPLC Pump Affect the Column and its Performance? – FAQ

If your HPLC pump produces a “pulse” (i.e. cyclic fluctuation in flow/pressure), this can cause problems for your Method and Column. The pump will not be delivering optimally Precise/Accurate Flow and this can cause your system to not meet System Suitability Criteria as well as other issues. Sudden changes in the Pressure can also cause […]

How to Calibrate UV-vis and HPLC Detectors with NIST Traceable Solutions Below 230nm

Is the Holmium Oxide Calibration Standard (cat# PQA-HOX-01) suitable for absorbance accuracy qualification?

No, the Holmium Oxide Calibration Standard (cat# PQA-HOX-01) is quite variable in its absorbance and is intended as a wavelength accuracy standard only. The appropriate item for this purpose is the 0.06000 mg/mL potassium dichromate solution, which is Solution #3 in the current UV kit. This is the basis of the current EP regulations, and it is […]

Simplifying getting started with HPLC Qualification using the HSQ Kit for HPLC.

As the first time, setting up an HPLC qualification method and using the HSQ Kit can seem a bit overwhelming. However, if you simply examine the data entry section of the Excel sheet provided in the HSQ Kit, the items that need to be entered and getting started are in order of their injection. There are 3 basic […]

Tip for using the wavelength calibration solution holmium oxide for HPLC UV detector qualification.

Performing the wavelength accuracy procedure from our HSQ and PQ Kits correctly is very easy and requires very little qualification solution. While pulling a vacuum and filling the flow cell it is possible that you may see small bubbles coming through the plastic tubing. These bubbles seem to come from the tubing connections. Pulling solution through over […]

Validation Protocol for the PQ Kit Template.

The validation protocol in the attachment is intended to document and validate the MicroSolv HPLC PQ Kit Excel Template used for HPLC Qualifications. The Excel file given for the latest version of the Performance Qualification is for 97-2003 Microsoft Excel Worksheet, but this is also compatible with Excel 2010. For operating in Excel 2010, you […]

What is the difference between Verification, Validation and Qualification?

In an LCGC Magazine article by Drs. Ira Krull and Michael Swartz they reference the International Organization for Standardization (ISO) as follows: “Validation is confirmation, through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled” whereas Verification is confirmation, through the provision of objective evidence that specified requirements have […]

Will the MicroSolv PQ Kits for UV-vis be appropriate for my Spectrophotometer? – FAQ

The new USP <857> guidelines are somewhat complicated, such that it is not easy to provide a simple answer. As an overview, in the old monograph, it was possible to simply qualify a spectrophotometer using a single stray light, wavelength and absorbance accuracy solution. The recent changes in the USP<857> states one must qualify over wavelength and […]

Category: Qualification Information