The short answer A control sample of finished product must be kept for at least one year after the expiry date, in its final packaging, in a quantity sufficient for at least two full re-examinations. All three of India, the…
Direct answer A polarimeter is calibrated by checking its scale accuracy against a certified quartz control plate and its scale linearity against sucrose solutions of known concentration, then comparing each reading with the value that standard is certified to give…
The short answer The harmonised pharmacopoeial method specifies exactly one thing about how long a friability test runs: 100 revolutions of a drum turning at 25 ± 1 r The “4 minutes” printed in most Indian SOPs is arithmetic (100…
Working standard in pharma: the short answer A working standard is an in-house lot of a drug substance that a Quality Control laboratory uses in place of the official reference standard for routine testing. Indian GMP calls it a secondary…
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…
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…
Principle of Dissolution Test Apparatus Dissolution is the analysis process in which the analyzed substance forms a solution. In this testing measurement of the content and rate of dissolving in the solution from a dosage form, such as a tablet,…
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…