General Topics - Pharma Egg

Feb82023 by KBS.No Comments

How to Test for Titanium Dioxide

Raw Material, General Topics, Quality Control, SOPs, Testing Methods

Titanium dioxide How to Test for Titanium Dioxide (TiO2) is a white, odorless, and tasteless powder that is widely used as a pigment in various products, including pharmaceutical tablets, sunscreen, food, and cosmetics. It is also used as a whitening and brightening agent, as well as an opacifying agent. Titanium dioxide has good durability and is resistant to discoloration and weathering, which makes it suitable for use in a wide range of applications. Some studies have suggested that Titanium dioxide may be harmful if inhaled or ingested in large quantities, but its safety has been widely evaluated and it is generally considered safe for use in personal care and cosmetic products. Purpose To ensure the quality of incoming raw material of Titanium Dioxide. Scope It is applicable for t...

Feb62023 by KBS.No Comments

How to Test Ivabradine HCl Raw Material

General Topics

It's important to follow the official pharmacopeias such as United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) for testing methods and acceptance criteria of How to Test Ivabradine HCl Raw Material Ivabradine HCl raw material. Description: Take about 1 g sample on butter paper and examine for color and appearance. The sample should be a white to off-white crystalline powder. Solubility: Freely soluble in Methanol, Chloroform, and Dimethyl Formamide: Weigh accurately about 1.0 g of the test sample into a cleaned and dry test tube. Add 10 mL of Methanol and mix the content. The solution should be clear. sample into a cleaned and dry test tube. Add 10 Weigh accurately about 1.0 g of the test mL of Chloroform and mix the content. The soluti...

Feb62023 by KBS.No Comments

How to Test Molnupiravir (Method of Analysis)

Testing Methods, General Topics, Quality Control, Raw Material, SOPs

The testing of Molnupiravir raw material can be done through various methods, How to Test Molnupiravir (Method of Analysis) including High-Performance Liquid Chromatography (HPLC): This method is used to determine the purity and potency of the raw material, Nuclear Magnetic Resonance (NMR) Spectroscopy: This method is used to identify the structure of the raw material, Infrared Spectroscopy (IR): This method is used to identify functional groups in the raw material, Mass Spectrometry (MS): This method is used to determine the molecular weight of the raw material, X-Ray Crystallography: This method is used to determine the crystal structure of the raw material. It is important to follow good manufacturing practices (GMP) and standard operating procedures (SOPs) during the testing process...

Feb62023 by KBS.No Comments

What is Raw Water Testing (Method of Analysis)

Testing Methods, General Topics, Quality Control, SOPs

Reverse osmosis water, or What is Raw Water Testing (Method of Analysis), is water that has undergone a reverse osmosis filtration process. In order to produce pure water, this process includes putting water through a semi-permeable membrane that filters out dissolved salts, minerals, and other contaminants. When water purity is crucial, reverse osmosis is frequently distilled for industrial and commercial applications as well as domestic water filtration systems. Distilled water is water that has through the distillation process, which entails heating water to the boiling point and then condensing the steam back into a liquid form, producing clean water with contaminants and minerals eliminated. This makes distilled water perfect for use in machinery, batteries, and scientific experime...

Feb42023 by XhaamiNo Comments

Tablet Making Process in Pharmaceuticals – Step by step guide

General Topics, Production

The tablet making process in the pharmaceutical industry is a crucial and complex procedure that involves several steps to ensure the final product is of high quality and meets the required standards. From the selection of active ingredients and excipients to inspection and packaging, each step plays an essential role in determining the quality of the final tablet. In this article, we will delve into the complete tablet manufacturing process in pharmaceuticals, providing an in-depth look at each step, from blend preparation to stability testing. With a focus on precision and expertise, this guide will provide a comprehensive overview of the art of tablet making in the pharma industry. The process of making tablets in the pharmaceutical industry typically involves the following steps: Ste...

Feb32023 by KBS.No Comments

Vendor Evaluation Procedure in Pharmaceuticals

Production, General Topics, SOPs

Vendor Evaluation Procedure in Pharmaceuticals qualification is the process of determining whether a vendor can provide the required goods or services to the standards that the purchasing company requires. This article describes in detail how to qualify raw material vendors, packaging vendors, and service providers. This also explains vendor evaluation and re-evaluation. The vendor Evaluation Procedure in Pharmaceuticals assessment is a process that businesses can use to determine whether prospective vendors and suppliers will be able to meet their organizational standards and obligations once they are under contract. The ultimate goal is to secure a portfolio of low-risk, best-in-class vendors and suppliers. PURPOSE: It is intended to provide a system to qualify a vendor /supplie...

Jan312023 by KBS.No Comments

SOP for Process Change Control in Pharmaceuticals

Production, General Topics, Quality Control, SOPs

A formal system by which qualified persons or Subject SOP for Process Change Control in Pharmaceuticals matter Expert of different departments review proposed or actual changes that might affect a validated status of facilities, system, equipment, Document or processes. SCOPE:- This procedure is to be followed while controlling process change in Pharmaceuticals Plant. OBJECTIVE:- To control process variability To operate the process smoothly. RESPONSIBILITY:- Plant Manager Quality Control Manager Quality Assurance Manager Inventory Control Manager Production Manager Maintenance Incharge Critical Process: Following are the critical processes in which change need control in order to control Process variability & for smooth operation: Change of...

Jan312023 by KBS.No Comments

Good Personal Hygiene in Pharmaceuticals

Production, General Topics, Quality Control, SOPs

Good Personal Hygiene in Pharmaceuticals is required in the pharmaceutical industries to protect the product and avoid any contamination that affects the quality of the medicinal product. Good Personal Hygiene in Pharmaceuticals Individuals are responsible for the quality of medicinal products and may therefore be collectively referred to as "staff". Purpose:- The purpose of this procedure is to prevent contamination of Products prepared at the Surge Plant by employees working or Vice Versa. Scope Good Personal Hygiene in Pharmaceuticals:- This procedure is applicable to all the Good Personal Hygiene in Pharmaceuticals working at, .................located HSE Statement:- N.A Responsibility:- Officer QC/QA in coordination with Manager QA/QMR will ensure that SOP has been successfull...

Jan302023 by KBS.No Comments

Washing and Cleaning of Laboratory Glassware

SOPs, General Topics, Quality Control

Washing and Cleaning of Laboratory Glassware isn't as simple as washing the dishes. Here's how to wash your glassware so that you won't ruin your chemical solution or laboratory experiment. For the Washing and Cleaning of Laboratory Glassware detergent and tap water are neither required nor desirable. You can rinse the glassware with the proper solvent, then finish up with a couple of rinses with distilled water, followed by final rinses with deionized water. Purpose:- The procedure is established to ensure the utmost cleanliness of the laboratory glassware for carrying out successful assays and tests without interference from the residues of the previous analysis. It is necessary to ensure the quality of future products handled in the equipment to prevent cross contamination and as a...

Jan302023 by KBS.No Comments

Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions

SOPs, General Topics, Quality Control

Professional quality solutions are possible when high quality and fresh chemicals and solvents are used, and meticulous procedures are followed. Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions of the reagents used in science are in the form of solutions which need to be purchased or prepared. Purpose:- To lay down a procedure for the Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions of shelf life to volumetric solutions and laboratory reagents used for chemical analysis. Scope of Preparation and Assigning Shelf Life to Reagents & Volumetric Solutions:- This SOP is applicable to all laboratory reagents and volumetric solutions used in analytical work for Preparation and Assigning Shelf Life to Reagents & Volumetric Soluti...