Even a well-maintained colloidal mill experiences recurring issues that lead to malfunction eventually, and usually, there are only several common causes for that: the gap drift, rotor/stator wear, improper feed rate, or a faulty mechanical seal. Moreover, preventing the issues from arising is significantly simpler and less resource-consuming than addressing them after they occur. For … Read more
Have you ever asked yourself why a tablet, which has passed all the other quality control tests, fails the QC bench? A disintegration test apparatus is used to determine whether a tablet or a capsule disintegrates within a specified time under defined conditions. The test is performed by vertically reciprocating the unit in a liquid maintained at human body temperature. This article describes the working principle of the disintegration test apparatus, its components, the procedure for the disintegration test, calibration, and the disintegration limits set by the manufacturers for different dosage forms. This information will help QC and manufacturing personnel to perform the disintegration test properly and release the batches of the pharmaceutical products.
Learn what FDA investigators actually flag most often when auditing pharmaceutical water systems — sampling gaps, sanitization failures, monitoring lapses, validation shortfalls, CAPA deficiencies, and broader GMP compliance issues.
Know the step-by-step procedure used to prepare and standardize 0.1M perchloric acid solution as per IP guidelines. Incorporates reagents, equipment, calculation, detection of endpoint, storage of reagents, and standardization with potassium hydrogen phthalate (KHP).
Preparation and standardization of 0.004 M benzethonium chloride solution with potentiometric titration with 0.1 M perchloric acid. It deals with preparation of reagents, calculation of standardizations, equivalence factor and recommendation on storage for pharmaceutical laboratory applications.
Here is the exact process for making and standardizing 0.05 M silver nitrate. Includes the chemicals, the titration procedure and the formula to calculate and storage condition
Know how to prepare 0.025 M sulphuric acid solution using anhydrous sodium carbonate, methyl red indicator, calculations and titration procedure.
Limit tests for heavy metals need not be confusing. This guide includes detailed protocols with equipment, reagent preparation and step-by-step instructions to perform a typical test procedure. For all of the Test A, B, C and D options, there are clear instructions to ensure your pharmaceutical quality control is accurate and on track. 1.0 Scope: … Read more
The solubility test is a basic test performed in the pharmaceutical laboratory to assess the solubility of a substance in a given solvent. This guide describes the entire solubility testing procedure, apparatus used, considerations for selection of solvents, temperature, and standard solubility classification from very soluble to practically insoluble. This step-by-step reference will help you to test accurately and fulfil the pharmaceutical quality requirements.
The Capreomycin Sulphate Colour of Solution Test is an important quality control test to check the appearance of a prepared capreomycin solution. This test is performed to ensure the solution meets the pharmacopoeial colour standards, which indicates that the product is of good quality and consistent.
This article describes the SOP for preparation and standardization of 0.1M ethanolic sodium hydroxide solution. It includes apparatus, reagents, preparation of the thymolphthalein indicator, preparation of sodium hydroxide solution, standardization procedure of benzoic acid, formula to calculate the molarity, storage conditions and reference as per IP norms. It is a guide for pharmaceutical quality control and analytical laboratories.
As one of the major pharmaceutical manufacturing cities of India, Ahmedabad has multinational companies like Zydus Lifesciences, Torrent Pharmaceuticals, Cadila Pharmaceuticals and Intas Pharmaceuticals. The companies are producers of generics, biosimilars, vaccines, injectables and APIs with the facilities located at Sanand, Moraiya, Changodar and Bavla (PHARMEZ) industrial estates. Working in tandem with the pharmaceutical ecosystem … Read more
Download the SOP for Additional Packing Material in pharmaceutical manufacturing. Learn the GMP-compliant procedure for requesting, issuing, approving, and reconciling extra packaging materials
Learn the differences between primary, secondary, and tertiary pharmaceutical packaging materials with practical examples of bottles, blister packs, cartons, vials, shippers, and pallets used in the pharma industry.
IND, or the Investigational New Drug Application, is a U.S. permission process required to move any new medicine or therapy from laboratory research to human testing, meaning clinical trials. For example, imagine scientists have developed a new medicine. They cannot directly test it on humans. First, they must submit proof to the U.S. drug authority through an … Read more
Self-inspection, also known as an internal audit, is a routine check that pharmaceutical companies run on their own to check the gaps between the procedures and documents. All manufacturing and quality teams must follow this process to maintain compliance. We can say it is a review that checks if daily work matches Good Manufacturing Practices … Read more