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  • Analytical Balance – Working Range

    Analytical balance and working range

    Analytical balances are the key instrument of quantitative analysis. It is used to accurately weigh samples and standards. It is one of the primary activities of the analysis process. Its industrial application includes pharmaceuticals, plastic, food, chemical manufacturing, calibration laboratories etc. Analytical balance is used for accurate weighing of samples and standards; it is one … Read more

    Analytical Method Development – Forced Degradation Study


    Analytical method development finalization for Drug Substance or Drug Product is dependent on finalization of Forced degradation studies or Stress studies as it indicates a clear scenario of potential degradant impurities which may arise during the course of study and we can be prepared for further preparation, isolation, and characterization of Impurities for Regulatory Requirement. … Read more

    Analytical Method Development Approach When Compounds Don’t Have UV Chromophore:

    Analytical Method Development Approach When Compound Don’t Have UV Chromophore

    High-performance liquid chromatography (HPLC) is one of the most important instruments used in the pharmaceutical industry. Most of the pharmacopeial monograph methods are based on HPLC with a UV-Visible detector and It is a useful analytical technique for qualitative and quantitative purposes. In some compound, there is a lack of or absence of chromophore which … Read more

    Assessment of USFDA Warning Letters & 483’s Related to Improper Handling of OOS Results


    The US Food and Drug Administration (FDA) inspection trend of recent warning letters is typically related to the deficient investigation of failure results, unacceptable examination of Out of Specification (OOS) outcomes, and ineffective corrective action and preventive action (CAPAs). The regulatory agency USFDA is controlling the drug substances or drug products manufactured and marketed in … Read more

    Chromatography Technique and its Applications

    Chromatogrpahy and its application

    Chromatography is a laboratory technique for the separation of mixtures of chemical substances into their components. The separations which are complicated are achieved rapidly and efficiently by chromatography techniques. Chromatography may be analytical or preparative, analytical chromatography is normally done with smaller amounts of material to establish the presence or measures the relative proportions of … Read more

    Computer System Validation in Pharmaceutical Industry

    Computer System Validation In Pharmaceutical Industry

    In the pharmaceutical industry, computer system validation (CSV) is essential for guaranteeing overall sufficient quality control of any final product. CSV is essentially a process used to track and verify different results, documents, and other validation activities. What is Computer system validation? CSV is a systematic process that involves a number of critical and important … Read more

    Custom Synthesis in the Pharmaceutical Industry

    Custom Synthesis in the Pharmaceutical Industry

    Custom synthesis in the pharmaceutical industry is an essential service. It involves the production of products tailored specifically to meet the customer’s requirements, including specific timelines, desired quantities, specified specifications, and process technology. In custom synthesis, the chemistry involved focuses on the synthesis and development of complex molecules, substances, chemicals, or compounds through various chemical … Read more

    Determination of Response factors of Impurities in Drugs by HPLC

    Determination of Response factors of Impurities in Drugs by HPLC

    Importance of Relative Response Factor in Impurities Quantification Impurities developed in active pharmaceutical ingredients (APIs) and in formulation products during the manufacturing process stages or during degradation need to be controlled. The isolation, identification, and quantification of these impurities are important for drug development and also as per the regulatory requirement and defined guidelines. Impurities … Read more

    Difference between HPLC and GC Technique

    Difference between HPLC and GC Technique

    HPLC (high-performance liquid chromatography) and GC (gas chromatography) are widely used separation techniques in pharmaceutical industries, industrial laboratories, and academia. High-performance liquid chromatography has applications in the field of pharmaceuticals, polymers; life sciences, etc. Gas chromatography has applications in pharmaceuticals, petroleum, petrochemical industry, etc. HPLC and GC operate on the same principle but with different … Read more