The short answer Calibrating a volumetric Karl Fischer titrator means determining the water equivalence factor (F) of the titrant — how many milligrams of water one millilitre of reagent consumes. Sodium tartrate dihydrate is the standard of choice because it…
Short answer HPLC separates the components of a mixture by pumping the sample, dissolved in a liquid mobile phase, through a column packed with a solid stationary phase under high pressure. Each component partitions between the two phases to a…
Technical reference · Reviewed and updated 27 August 2026 · Dimensions and operating limits quoted from USP General Chapter 801 The short answer A dropping mercury electrode (DME) is a mercury electrode formed by a sequence of mercury drops falling…
Short answer. Under Ph. Eur. 2.9.5 a powder for parenteral administration with an average mass above 40 mg is tested by weighing 20 containers: not more than 2 may deviate from the average by more than 10%, and none by more…
Short answer An autoclave sterilises by holding a load in saturated steam under pressure, so that condensing steam gives up its latent heat directly on every surface it touches and irreversibly denatures microbial protein. Pressure is only the means of…
The short answer ALCOA is five data-integrity attributes — Attributable, Legible, Contemporaneous, Original, Accurate. ALCOA+ adds four more (Complete, Consistent, Enduring, Available) for nine. ALCOA++ adds a tenth, Traceable, and is the form the European Medicines Agency uses for clinical-trial…
Comprehensive Guide to Calibration of Melting Point Apparatus Introduction: A melting point apparatus is used to measure the melting point of a solid (powder) substance. The melting point is the temperature at which a powder or solid substance gets converted…
By Darshan Singh, QC/QA and regulatory affairs, 23 years in pharmaceutical quality. Revised 21 September 2026 against IPC’s harmonised draft of IP 2.5.1, USP <701>, Ph. Eur. 2.9.1 and JP 6.09. Calibration in one card A disintegration test apparatus is…
Glassware used in Laboratory is very important equipment for valid analysis practices. If a 1ml pipette delivers 0.01 ml less or more in testing, the result of the analysis may differ more than 10 percent from actual results, so that…
Short answer. An out-of-specification result is a laboratory test result that falls outside a specification. Environmental monitoring data are not measured against specifications at all. They are measured against alert levels and action limits that the manufacturer sets from qualification…