Learn About Standard Operating Procedure for Handling of Deviations in pharmaceuticals | Types of deviations | Deviation Flow chart | Devations Guidelines | Deviation Numbering | Deviation management. 1.0 OBJECTIVE: 1.1 To lay down that deviations from manufacturing instructions and quality-related procedures are recorded, investigated, and evaluated for their impact on product quality in a … Read more
In this discussion, we will delve into two very important terms associated with drug products: drug product assay and drug product potency. The aim is to clear vision on their interrelation, differences, and significance, as guided by the ICH guideline Q2 R2, which focuses on analytical method validation. Drug Product Assay Definition and Purpose A … Read more
The instrument being discussed in this context is known as a Flow Injection Analyzer (FIA). Its primary function is to automate several processes typically associated with conventional wet chemistry procedures. Specifically, the Flow Injection Analysis is designed to perform tasks such as automatically picking up samples, mixing them with the required reagents, and subsequently detecting … Read more
A Dissolution Test is used for in vitro Testing of the Tablets and Capsules. Dissolution provides the product Release info to know the drug delivery. Dissolution apparatus are used throughout the product development life cycle, from Product release to stability testing and study of the product data from product to product. Then after passing or approval from the … Read more
Preparation and Standardization of 0.01 M Sodium Tetraphenylborate (C6H5)4BNa) solution and calculating formula in Pharmaceutical labs. Name: 0.01 M Sodium Tetraphenylborate (C6H5)4BNa) Reagents: Sodium TetraphenylborateSodium HydroxideAluminium HydroxideSodium ChlorideCetylpyridinium ChloridePotassium Chloride Method of Preparation: Method of Standardization: Calculation: The calculation formula is : Where ‘a’ is the volume of 0.005 M cetylpyridinium chloride required without potassium … Read more
Preparation and Standardization of 0.1 M Tetrabutylammonium Hydroxide (C16H37NO) Solution in Pharmaceutical Labs. Name: 0.1 M Tetrabutylammonium Hydroxide (C16H37NO) Reagents : Preparation of 0.1 M Tetrabutylammonium Hydroxide: Method of Standardization: Storage: Store below 25°C & store in an amber-colored bottle. Protect exposure from CO2 & water. Shelf life: The shelf life of the above solution … Read more
Column Cleaning, Regeneration, and Storage of Silica Based Columns are necessary to prevent unnecessary problems during the Process. So when you’re using those in-line filters or guard cartridges for your HPLC columns, it’s like giving them armor against getting clogged or stuff sticking to them. But you know what? Even with these guard things, over … Read more
Why is HPAC Mobile phase Degassing done? When different liquids mix in HPLC analysis, bubbles forming can cause problems. To avoid this, we removed the bubbles by degassing the liquid used in the analysis. Unstable and Noisy Baselines Lower flow rate precision of pump due to cavitation in piston chamber or effect on check valve … Read more
Preparation and Standardization of 0.1 N Perchloric acid (Non-Aquos by using glacial acetic acid and crystal violet solution as indicators in Pharmaceuticals. Apparatus and Reagents Requirements: Apparatus: Conical Flask, Volumetric Flask, Reflux condenser, Measuring cylinder, Burette, Pipette and Burette Stand. Reagents: Preparation of 0.1 N Perchloric acid Standardization of 0.1 N Perchloric acid Calculation: N1V1=N2V2 … Read more
Here is a detailed discussion on How to Prepare and Standardization of Potassium Permanganate (1M, 0.1M, 1N, 0.1N) solution by using different reagents in Labs. Preparation and Standardization of 1M Potassium Permanganate Potassium permanganate – M.Wt – 158 Preparation of 1M Solution of Potassium Permanganate: Principle: In volumetric analysis, many reactions involve oxidation and reduction. … Read more
Preparation and Standardization of 0.1 M Sodium Thiosulfate (Na2S2O3) solution in pharmaceutical labs. Aim: 0.1 Molar Thiosulfate (Na2S2O3) solution Preparation and Standardization Materials/Reagents: 1.0 – Sodium Thiosulfate2.0 – Sodium Carbonate3.0 – Potassium Bromate4.0 – Potassium Iodide5.0 – Hydrochloric Acid6.0 – Starch Solution Principle: Principle: This method uses a standard process called redox titration with iodometric … Read more
Preparation and Standardization of 0.1 M KOH Solution by using HCL and phenolphthalein as an indicator in Pharmaceutical Labs. Aim: To Prepare and measure 0.1 M KOH solution with HCl. Materials and Reagents Requirements: Glass: A burette, burette stand, conical flask, volumetric pipette, beaker, volumetric flask, funnel, glass rod, and a wash bottle.Chemicals: Potassium hydroxide … Read more
Preparation and Standardization of 0.1N Silver Nitrate (AgNO3) Solution in pharmaceutical labs by using below steps: Steps involved in the Preparation and Standardization of 0.1N Silver Nitrate Step-1: Reagent preparationStep-2: AgNO3 solution preparationStep-3: AgNO3 solution StandardizationStep-4: Calculation Preparation of 0.1 N AgNO3 solution: Step-1: Reagent Preparation: (Pottasium Chromate solution) Step-2: AgNO3 solution preparation: Step-3: AgNO3 … Read more
Aim: Preparation and Standardization of 0.1 M Silver Nitrate (AgNO3) solution by using sodium chloride in Pharmaceutical Labs. Name: 0.1 M Silver Nitrate (AgNO3) Reagents used to Prepare and Standardization of 0.1 M AgNO3 : Glassware: Volumetric Flask, measuring cylinder, Burette, Conical Flask, beaker, and Pipettes. Principle: In the lab, we used a process where … Read more
Preparation and Standardization of 0.1 M Sodium Nitrite (NaNO2) by using Sulphanilic acid in Pharmaceutical Analysis. Chemical Name: 0.1 M Sodium Nitrite (NaNO2) Reagents: 1.0 Sodium nitrite2.0 Sulphanilic acid3.0 Potassium bromide4.0 2M Hydrochloric Acid5.0 Starch iodide paper Preparation of 0.1 M Sodium Nitrite To make this solution, take 7.5 grams of sodium nitrite and dissolve … Read more
Preparation and Standardization of 0.05 M EDTA Solution by using disodium edetate and Eri Chrom Black T as an indicator in Pharmaceutical Labs. EDTA, which stands for Edathamil, or Ethylene diamine tetra acetic Acid, is a well-known substance used in managing and treating heavy metal toxicity. Preparation of 0.05 M EDTA Solution: To prepare a … Read more