QC Analytical Chemistry

Every QC Analytical Chemistry course in the Zentrum24 Academy library. Read the first two pages of any of them free.

• Bacterial Endotoxin Testing (BET) ProceduresBacterial endotoxin testing by LAL — gel clot, turbidimetric and chromogenic methods, maximum valid dilution, controls, and reporting the result in EU/mL.
• Bioburden Method Suitability and Microbial Recovery ProceduresProving the method recovers what is there — challenge organisms, neutralising inhibitory product, recovery criteria, and when suitability must be repeated.
• Capillary Viscometer Analysis of Drug Product LiquidsMeasuring kinematic viscosity with a capillary viscometer — tube selection, bath temperature, flow timing, calculation, and the errors that skew a result.
• Finished Product Sterility TestingSterility testing by membrane filtration and direct inoculation — isolator technique, media and incubation, sample plan, and investigating a positive.
• Bioburden Enumeration and Testing — cGMP Training GuideCounting bioburden in product and in-process samples — sample handling, filtration and plating, incubation, calculation, and acting against the limit.
• Pharmaceutical Microbiological Testing ProtocolsThe compendial microbiology test set — bioburden, endotoxin, sterility, growth promotion and method suitability — and how each fits the control strategy.
• Standard Procedures for Injectable Particulate Matter AnalysisSub-visible particulate testing by light obscuration and microscopy — sample preparation, blanks and environment, limits, and confirming a high count.
• Sterility Method Suitability and Microbial Challenge ProtocolsDemonstrating the sterility method is not inhibited — challenge organisms and inoculum, rinse volumes and neutralisation, acceptance, and repeat triggers.
• Uniformity of Dosage Units by Mass Variation TestingUniformity of dosage units by mass variation — when it may replace content uniformity, sample size, acceptance value calculation, and the second-stage test.