The control sample is a portion of a finished product or raw material’s specific lot or the packing material’s few units, preserved in a control area for future analysis and reproducing purposes. Retention of the control sample is a part…
In one line: a stability chamber holds a fixed temperature and relative humidity by running conditioned air in a continuous loop past a heater, a refrigeration coil and a humidifier, with a PLC trimming each one against sensors mounted in…
In one paragraph Gas chromatography separates a mixture by repeatedly partitioning volatile components between an inert carrier gas (the mobile phase) and a liquid or solid film coated inside a capillary column (the stationary phase). Components that spend more time…
Short answer An SOP for fumigation of microbiology lab is only defensible if the cycle is validated and if re-entry is decided by a measured fumigant concentration — never by smell or by elapsed time. Fumigation is whole-room bio-decontamination, not…
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…
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…
An autoclave is a critical piece of equipment in pharmaceutical manufacturing and microbiology laboratories that achieves sterilization through moist heat under controlled pressure. The principle underlying autoclave sterilization—moist heat sterilization—works by generating saturated steam at temperatures of 121–134°C and pressures…
Functions of Quality Control in the Pharmaceutical Industry Introduction: Quality Control is a critical part of a pharmaceutical company. It is a testing laboratory in the pharmaceutical industry. It performs not only the testing of material but also forces all…
Working standards are an integral part of any pharmaceutical laboratory. The working standard allows knowing the assay value of any tested product against the potency of the working standard. There are two types of standards in the laboratory (i) Reference…