Can I use qualification solutions with different lot numbers?

If you require or would like to use a mix of different lot numbers for solutions from the MicroSolv HSQ™, UV-vis™ or PQ™ Kit solutions, this is an acceptable protocol under some conditions: You cannot mix different lots among the L1-L6 solutions. These solutions are for UV detector linearity and are designed to be used as a set. However, you can for […]

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Can I use the HSQ Kit for IQ and OQ as well as PQ?

From USP <1058>: Installation Qualification (IQ) – The documented collection of activities necessary to establish that an instrument is delivered and designed as specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument. Operational Qualification (OQ): The documented collection of activities necessary to demonstrate that an instrument will function according […]

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Can I use the MicroSolv HSQ Kits for HPLC to qualify a UHPLC Instrument?

Fundamentally, UHPLC is no different from conventional HPLC. All of the same principles apply, only UHPLC uses higher pressure pumps, lower extra-column system volume, and so on. You can even use the same standard 4um column to qualify the UHPLC instrument. Whether you are qualifying a UHPLC or HPLC instrument, the Kit provides the same […]

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Do you supply an SOP template with the HSQ Qualification Kit

We no longer supply a formal template or extensive written SOP for Performance Qualification. However, the Excel template that is provided with the HSQ (High Speed Qualification) kit can be a model for your SOP taking into account the tests that you will do and the objective of each test. Also, the Quick Start Instructions […]

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Does the HSQ Kit Qualify Quaternary HPLC Pumps? – FAQ

Yes, the HSQ Kit™ will work on many types of pumps; from single, binary, and also quaternary pumps.  For Gradient Qualification Tests, the base method is called “GRDAB” for “Gradient, pump A/B*”, where the “*” designates that the B fluid circuit is “visualized” with the addition of the Gradient Visualization Solution (GVS). For ternary or […]

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Does the method used in the HSQ Kit for HPLC need to be validated?

Validation of the method would not be applicable since it is used to qualify the instrument itself.  Suppose you’re talking about LOD or LOQ of the HPLC method as a validation parameter, for example. You wouldn’t need to validate this parameter in the HSQ Kit method because its calculation first assumes that the detector is […]

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Fluctuations in readings when using the UV-Vis Calibration Kit

Fluctuations in readings in a UV-vis instrument are almost certainly due to a failing lamp.  A typical insturment which uses a xenon lamp is normally rated for only about 500 hrs, while a deuterium can range from 1,000-3,000 hrs.  However, they will sooner or later.  If you are not sure of the hours on the lamp, I would […]

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How do I clean the PQ or HSQ Kit™ Column?

“Since the column is used only for test purposes, it should never become contaminated, and should require only a minimal 10-15 minute equilibration prior to starting the sequence. If it ever requires cleaning, flush for 15-30 minutes with 50:50 acetonitrile : water.” —User manual, Rev. 1.08, section II.3, pg. 9. PQ & HSQ Kits for […]

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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 […]

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How do I measure pump flow accuracy in HPLC?

Use a dry 5ml volumetric flask and a calibrated stopwatch to confirm the flow accuracy at 1.0 mL/minute. Note that this flow rate check is not meant to replace the typically more extensive Operational Qualification checks at several flow rates. Rather it is to document the suitability of the pump to perform various PQ Test protocols described […]

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How do I store the HPLC column supplied in the HSQ kit?

One of the best features of the MicroSolv HSQ Kit™ is that the kit was designed for ease and speed. The HPLC Column is shipped and stored in the same mobile phase that is used during the testing. The column is always ready to go with minimal equilibration time. The mobile phase/storage solvents were chosen […]

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I am getting a different retention time for the peaks in the Resolution Test Mixture on different systems. What impact does this have on the integrity of my data?

No impact at all. There will certainly be mobile phase preparation differences, aging of columns, etc. The HSQ kit instructions call for adjustment of the mobile phase to meet system suitability, which for example in our C of A, calls to adjust the mobile phase to achieve a 4-5 minute retention time window. Keep in […]

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What are the concentrations used in the Refractive Index Qualification Kit?

The solutions of the HPLC Performance Qualification Solutions for Refractive Index and Light Scattering Detectors have the following certified concentrations:   Solution Header 2  L1  0.200 mg/mL ± 0.0002  L2  0.400 mg/mL ± 0.0002  L3  0.500 mg/mL ± 0.0002  L4  1.00 mg/mL ± 0.001  L5  1.50 mg/mL ± 0.001  L6  2.00 mg/mL ± 0.001   […]

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What are the peaks/analytes in the Resolution Test Mixture supplied in the HSQ Kit for HPLC?

The peaks/analytes elute in the following order for the PQ Kit™: Uracil Theophylinne Caffeine 8-Chloro-Theophylline For more recent and more efficient HPLC’s, the HSQ Kit™ has a different Resolution Test Mixture with one additional, earlier eluting peak. This additional peak allows the HSQ Software to best determine your system’s Extra Column Volume. This extra peak is not required […]

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