CLICK HERE 👇   Grades of chemical reagents used in the laboratory

Installation qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument. Before installation : • Obtain manufacturer’s recommendations for installation site requirements. • Check the site for the fulfillment of the manufacturer’s recommendations (utilities such as electricity, and environmental conditions such as humidity and temperature). • Allow sufficient shelf space for the equipment, SOPs, operating manuals and software. During installation : • Compare equipment, as received, with purchase order (including software, accessories, spare parts) • Check documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificates) • Check equipment for any damage • Install hardware (computer, equipment, fittings and tubings for fluid connections

Design qualification (DQ) describes the user requirements and defines the functional and operational specifications of the instrument. It should ensure that instruments to be purchased have the necessary functions and performance that will enable them be suitable for the intended applications. Design elements : 1) Intended use :  Analysis of drug compounds and impurities.  2) User requirement specification for the HPLC analysis :  - Up to 100 samples / day.  - Automated over-night analysis.  - Limit of quantitation: 0.1%.  - Automated confirmation of peak identity and purity with diode-array detection.  - Automated compound quantitation and printing of report.  3) Functional specifications : - Pump : Binary or higher gradient.  - Detector : UV/Vis Diode-array, 190-900 nm.  - Autosampler : 100 samples, 0.5 ul to 5 ml sample volume.  - Column compartment : 15 to 60 Deg C, peltier controlled.  - Computer : System control, data acquisition for signals .  and spectra, peak integration an

  1- Water : Acetonitrile (45 : 55) 2- Water : Methanol (45 : 55) 3- Water : Methanol (32.2 : 67.8) 4- A)  Organic : Buffer (3 : 2)      B) Organic : Buffer (3 : 2) 5- Methanol : Water (80 : 20) 6- Methanol : Water (70 : 30) 7-  A) Acetonitrile : Water (30 : 70)       B) Acetonitrile : Methanol : Water                             (15 : 15 : 70)       C) Acetonitrile : THF : Water                             (15 : 15 : 70)

 1- Asymmetry factor 2- Tailing factor 3- Theoretical plate count 4- Resolution 5- Peak to valley ratio 6- Signal to noise ratio

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