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…
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…
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…
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…
Comprehensive Guide: SOP for Preventive Maintenance of HPLC HPLC is a very sophisticated instrument in the laboratory. This machine requires high alertness and care while operating. HPLC is a widely used analytical method in the pharmaceutical industry. It is a…
The procedure for preventive Maintenance of Lab Instrument is documented and approved by the Quality Control Manager and Quality Assurance manager after duly verification. It is very essential to prevent lab instruments from any breakdown during their operation and use.…
A fluidized Bed dryer is an important equipment in the granulation section of the tablet manufacturing area of a pharmaceutical manufacturing company. It is necessary to have a written document for the cleaning of FBD in the form of an…
The quality of products manufactured in a pharmaceutical company depends on the environmental conditions provided during it’s manufacturing. Pharmaceutical products are highly sensitive to the temperature and humidity of the premise where they are being manufactured or stored. Most of…
The pharmaceutical industry is a highly regulated industry by Drug Departments. Every action in the pharmaceutical manufacturing company needs to be documented and verified. Action without documentation is understood as manipulation or out of specification because without SOP no action…