Bracketing and Matrixing Designs for Stability Testing

Reduced study designs, in the context of pharmaceutical development and stability testing, refer to approaches that allow for a reduction in the number of samples and/or time points for testing while still ensuring the reliability and validity of the data. The concept of reduced study designs aligns with the guidelines provided by the ICH.. TheseContinue reading “Bracketing and Matrixing Designs for Stability Testing”

5 Why tools for Root cause analysis in pharmaceuticals

Originating in the manufacturing industry, the “5 Whys” analysis technique has found effective adaptation and application in various fields, including pharmaceuticals. It involves asking “why” multiple times (typically five) to dig deeper into the root causes of a problem. In the context of pharmaceuticals, the 5Whys tool can help identify the underlying causes of qualityContinue reading “5 Why tools for Root cause analysis in pharmaceuticals”

Evaporative Light Scattering Detector(ELSD)

ELSD stands for Evaporative Light Scattering Detector. It serves as a type of analytical instrument in chromatography for detecting and quantifying non-volatile compounds lacking a natural chromophore or fluorophore. It proves especially valuable when analyzing compounds that UV, fluorescence, or conductivity detectors, commonly used in chromatography, cannot detect. How ELSD Works: Applications of ELSD: InContinue reading “Evaporative Light Scattering Detector(ELSD)”

Refractive Index Detector (RID)

A Refractive Index Detector (RID), also known as a Refractometer or Refractive Index Detector, is a detection device commonly used in High-Performance Liquid Chromatography (HPLC) and other liquid chromatography techniques. RIDs operate based on the principle of measuring changes in the refractive index of a sample as it elutes from the chromatographic column. Here areContinue reading “Refractive Index Detector (RID)”

Fluorescence Detectors(FLD)

Fluorescence Detector (FLD) is a specialized analytical instrument used to detect and quantify fluorescent compounds in various samples. It operates on the principle of fluorescence, a process where molecules absorb light at one wavelength and then re-emit it at a longer wavelength. Here are the applications and uses of fluorescence detectors: Applications of Fluorescence Detectors:Continue reading “Fluorescence Detectors(FLD)”

Diode Array Detector

Diode Array Detector (DAD), also known as a UV-Visible Detector, is a type of detector commonly used in analytical chemistry techniques like High-Performance Liquid Chromatography (HPLC) and other forms of liquid chromatography. It differs from a single-wavelength UV detector in that it can simultaneously measure absorbance at multiple wavelengths across the UV-Visible spectrum. Here areContinue reading “Diode Array Detector”

UV VIS Detector and it’s application

A UV-Vis (Ultraviolet-Visible) detector is a common analytical instrument used in chemistry and biochemistry to measure the absorbance of ultraviolet and visible light by a sample. Principle and Component of UV-Vis Here are some key points about UV-Vis detectors and their applications: Application of UV-Vis New Watches Collection Limitation: Limitations: UV-Vis spectroscopy is limited toContinue reading “UV VIS Detector and it’s application”

Hausner’s Ratio

Hausner’s ratio, also known as the Carr’s compressibility index, is a measure used in the pharmaceutical industry to assess the flowability and compressibility of powders and granular materials. It is a simple way to predict how well a powder will flow and how easily it can be compressed into tablets or other solid dosage forms.Continue reading “Hausner’s Ratio”

ICH Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines to ensure the quality, safety, and efficacy of pharmaceutical products. These guidelines cover various aspects of drug development and regulation, including: Q1: Stability Testing of New Drug Substances and ProductsQ2: Validation of Analytical ProceduresQ3: Impurities in New Drug SubstancesQ4:Continue reading “ICH Guidelines”

Dissolution Testing

Dissolution testing is a critical process in pharmaceutical development. Dissolution testing is a critical quality control and research technique used in the pharmaceutical industry to assess the rate and extent of drug release from a solid dosage form (e.g., tablets, capsules) into a dissolution medium that simulates physiological conditions. The results of dissolution tests areContinue reading “Dissolution Testing”

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