This topic explains the legal provisions for obtaining loan license and repacking license under Indian drug regulations and their specific requirements. The Act provides provisions for Loan Licenses and Repacking Licenses to enhance flexibility and efficiency in drug manufacturing and distribution. Loan License A Loan License allows a license holder to permit another entity to … Read more
Legal Definitions of Schedules under the Drugs and Cosmetics Rules, 1945, framed under the Act and Rules, are divided into various Schedules that specify requirements related to drugs and cosmetics. Some important Schedules include: Schedule C and C(1) Pertains to biological and special products like sera, vaccines, insulin, and other biological products. They have stricter … Read more
Study of Physicochemical Characteristics of Drug Substances Study of physicochemical characteristics of drug substances involves analyzing solubility, pKa, stability, and other properties of drug. These characteristics influence the drug’s behavior during formulation, processing, and storage, as well as its bioavailability and therapeutic performance. Key Physicochemical Characteristics of Drugs: Physical Properties: Physical form (crystalline vs. amorphous) … Read more
The primary goals and objectives of Pre-formulation studies are: Understand the Drug’s Characteristics: To determine the physical and chemical properties of the drug substance. To understand how these properties influence the drug’s performance, stability, and compatibility. Support Formulation Development: To guide the selection of excipients, processes, and packaging materials for dosage form development. To identify … Read more
Energy-rich compounds play a fundamental role in cellular metabolism and energy transfer. Energy rich compounds can be classified based on their structure, functional roles, and mechanisms of energy storage or transfer. 1. Nucleotide-Based Energy Carriers These compounds contain nucleotide structures and are primarily involved in energy transfer and signal transduction within cells. Adenosine Triphosphate (ATP): … Read more
Energy-rich compounds are essential for cellular metabolism, acting as molecular energy stores and carriers. These compounds release significant energy upon breaking high-energy bonds, driving various biological processes. Key Energy-Rich Compounds Adenosine Triphosphate (ATP) Structure: Adenine base, ribose sugar, and three phosphate groups. Function: Primary cellular energy currency, providing energy for muscle contraction, active transport, and … Read more
Redox potential (Eh) is a measure of a chemical species’ tendency to gain (reduction) or lose (oxidation) electrons, crucial in biochemical energy transfer and electron transport processes. Basics of Redox Potential Definition: Indicates a molecule’s ability to accept (oxidizing agent) or donate (reducing agent) electrons. Expression: Measured in volts (V) or millivolts (mV) relative to … Read more
The relationship between free energy (G), enthalpy (H), and entropy (S) is fundamental in biochemistry, determining the spontaneity and direction of chemical reactions in biological systems. These relationship between free energy (G), enthalpy (H), and entropy (S)thermodynamic parameters are interconnected through the Gibbs free energy equation, which predicts reaction feasibility. Gibbs Free Energy Equation The relationship … Read more
Exergonic and endergonic reactions are two types of chemical processes classified by their energy changes. An exergonic reaction releases free energy to the surroundings, resulting in a negative ΔG (ΔG < 0). An endergonic reaction requires an input of free energy from the surroundings, resulting in a positive ΔG (ΔG > 0). 1. Exergonic Reactions … Read more
The legal process for manufacture of drugs for test examination and analysis under Indian drug laws and regulatory provisions. Manufacturing drugs for non-commercial purposes, such as testing, examination, and analysis, is allowed under specific conditions: Key Provisions: Purpose-Specific Manufacturing: Drugs must be used strictly for clinical trials, research, or quality analysis, not for commercial sale. … Read more
