How to prepare 0.1M H2So4?

How to prepare 0.1M H2So4? Sulfuric acid (H2SO4) has a molecular weight of 98 g/mol and a density of 1.84 g/ml. The following describes how to prepare 0.1M H2SO4: Preparation …

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What is Informed Consent in Clinical Trial?

Informed Consent in clinical trial Informed consent stands as a foundational ethical and legal principle within the realm of clinical trials and medical research. It constitutes a voluntary and informed …

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7 Key Principles of ICH GCP E6 Guidelines?

What are key Principles of ICH GCP E6 guidelines? A good clinical practice (GCP) guideline for clinical studies involving human beings is called ICH E6. The International Council for Harmonization …

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What are the 12 principles of GCP trials?

Principles of GCP trials: The guiding gcp principles listed below offer a flexible framework for conducting clinical trials. They are set up to offer direction throughout the clinical trial’s duration. …

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What Is GCP Trials in pharma?

GCP Trials GCP stands for Good Clinical Practices in the pharmaceuticals industry. GCP Trials (Good Clinical Practices) are ethical and scientific standards for designing, recording, and reporting human research trials. …

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What is an ETMF in pharma?

What is an eTMF? TMF is stands for Trial Master File and eTMF stands for Electronic Trial Master File. Let’s understand What is an eTMF and TMF? Definition of Trial …

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How to Prepare 0.5M Sulfuric Acid?

How to Prepare 0.5M Sulfuric Acid? The molecular weight of Sulfuric acid (H2SO4) is 98 g/mol and the density of H2So4 is 1.84 g/ml. Here is procedure for preparation of …

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Why Water is Neutral?

Why Water is Neutral? What could be the reason for water to be considered as a neutral? Let’s understand, The molecular formula for water is H2O, it means water has …

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Does Clinical Trial Manager Salary is 10 lacs?

Clinical trial managers are essential in guiding the complex process of carrying out clinical trials in the fields of clinical research and medication development. Questions concerning their compensation for their …

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What is Molarity of 37% HCl?

Molarity of 37% HCl Solution Hydrochloric Acid is nothing but the hydrogen chloride gas aqueous solution. The molar mass of hydrochloric acid is 36.6 g/mol and the density of 37% …

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What is Purpose of Stability Testing?

The Purpose of stability testing: The stability testing is performed in pharmaceuticals industry for the manufactured drug product to understand the drug behavior throughout the time period. “The purpose of …

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What Is Density of HCl?

Density of HCl: HCl is short form of a Hydrochloric Acid. It is an aqueous solution of Hydrogen chloride. Hydrochloric acid is classified as a strong acid. The molecular weight …

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What Are Worldwide Clinical Trials Locations?

Worldwide clinical Trials Locations: Worldwide clinical trials are conducted in various locations across the globe. These trials take place in numerous countries, regions, and medical institutions to ensure a diverse …

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How HPLC different from GC?

High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are both methods within chromatography employed to separate and analyze compound mixtures. Nevertheless, they contrast in their underlying principles, applications, and …

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What is Flame Photometer Principle in pharma?

Flame Photometer Principle: Flame photometer is widely used technique to determine the concentration of alkali or alkaline earth metals, such as Sodium, Potassium, Calcium, Barium, Lithium. Flame photometry is quantitative …

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SOP for Calibration of Refractometer?

Calibration of Refractometer: 1.Objective: To lay down a procedure for calibration of Refractometer. 2. Scope: This procedure is applicable to Quality control laboratory for make Anton Paar and Rudolph. 3. …

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How HPLC works in pharma?

How HPLC works in Pharma? High-Performance Liquid Chromatography (HPLC) is an analytical method used for separating, identifying, and quantifying components within a mixture. This technique relies on chromatography principles, involving …

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How to prepare pH buffer solutions?

How to prepare pH buffer solutions: The reagent required for buffer solution preparation are; Preparation of Reagents: Potassium Tetraborate 0.05M (pH 1.68 at 25°C): Dissolve 3.1525 g of potassium tetraborate …

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SOP for Authorization of Designee in pharma

SOP for Authorization of Designee: 1.Objective: To lay down the procedure for Authorization of designee. 2.Scope: The procedure is applicable to all unit operation of company. 3. Responsibilities: Role Responsibility …

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How to prepare 0.5M HCl Solution?

How to prepare 0.5M HCl Solution? For HCl, the molecular mass and equivalent mass both are equal due to the availability of only one hydrogen ion. Most HCl present in …

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SOP for Operation of Refractometer

Operation of Refractometer: 1.Objective: To lay down the procedure for Operation of Refractometer. 2. Scope: This SOP is applicable to Quality Control Lab . 3. Responsibilities: Role Responsibilities Department Analyst …

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What is molality in pharmaceuticals?

What is molality in pharmaceuticals? Molality is nothing but the ratio of moles of solute to the kilogram of solvent. or molality (m) is a unit of concentration that measures …

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What is Molarity in pharmaceuticals?

What is Molarity in pharmaceuticals? Molarity is moles of solute to the volume of solution in litre. or In chemistry, molarity (M) is a unit of concentration that measures the …

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What is Normality in pharmaceuticals?

What is Normality? The number of gram equivalent weight of a solute into one litre of a solution is called as Normality. This solution is also called as equivalent concentration. …

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Important definitions related to safety

What are the Important definitions related to safety? Here we will understand what are the important terminologies are in the safety and their meaning. Flash Point: Lowest temperature at which …

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Patient safety in clinical trials

Patient safety in clinical trials in pharma: Patient safety is a top priority in clinical trials. Clinical trials are subject to strict ethical guidelines and are closely monitored to ensure …

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Preparation of 0.05M Disodium Edetate VS

Preparation and standardization of 0.05M Disodium Edetate VS: Reagent Used: Sodium Hydroxide TS: Dissolve 4.0 g of sodium hydroxide in water to make 100 ml. Dilute Hydrochloric Acid: Prepare by …

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Q3 ICH Guidelines for Impurities

Q3 ICH Guidelines for Impurities: Q3A (R2): Impurities in New Drug Substances: First recommended for adoption at Step 4 of the ICH Process on 30 March 1995, the guideline was revised under Step …

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ICH Guideline: Q2 Analytical Validation

Q2 Analytical Validation: The guideline Q2 analytical validation identifies validation parameters that are needed for various analytical methods. Here are two revisions of the Q2 analytical validation guideline; Q2(R1): Validation …

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ICH stability Guidelines Q1A – Q1F

ICH stability Guidelines Q1A to Q1F: This Guidelines have been developed by the appropriate ICH Expert Working Group and have been subject to consultation by the regulatory parties, in accordance …

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Top 11+ Stability Chamber Manufacturer in pharma

Stability Chamber Manufacturer: Many stability chamber manufacturers and suppliers are available in the market, some major manufacturers are listed below: Also Read: Refer YT Channel: Pharmabeejpro

What is Accelerated Testing In Pharma?

What is Accelerated Testing? Accelerated stability testing in stability study is designed to increase the rate of chemical degradation or physical change of drug substance or drug product by changing …

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How To Perform Limit Test For Arsenic?

According to different pharmacopeia, procedures to perform the limit test for arsenic are different. Here is only the limit test for arsenic as per USP. But first, need to understand …

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What does GMP in pharma help us to achieve?

GMP in pharma help use to achieve: GMP in pharmaceuticals, prevents any substandard, adulterated and unsafe products from being introduced into both national and international markets. GMP protects the consumer …

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What is an Incident in pharma?

What is an Incident? An Incident is an unplanned and unexpected event which which may result in an injury or damage to the plant, equipment, machinery, material or both or …

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Correction-corrective Action and preventive action

Correction-corrective action and preventive action in pharma: Correction-corrective action and preventive action are the 3 key definitions used in the pharmaceutical industry while investigating. Let’s understand the definitions of all …

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Dissolution Apparatus Calibration procedure

Dissolution Apparatus Calibration procedure: There are 2 types of dissolution calibration performed in the pharmaceutical industry, 1. Physical calibration and 2. Chemical calibration. In physical calibration, there are 11 parameters …

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Difference between OOS-OOT-OOC-OOE

Difference between OOS-OOT-OOC-OOE: When it comes to handling deviations in analysis results, the terms OOS, OOT, OOC and OOE always come up. But how are these terms defined? Out-Of-Specification (OOS)Results: …

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Why is data integrity important in pharma?

Pharmaceutical companies tout the safety of their new drugs. However, when FDA inspectors visit the production facility, the work is immediately halted; vital quality control data has been lost. Data …

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What is UPLC Principle in pharma?

UPLC Principle: It is a technique used to separate any sample into its constituent parts via liquid chromatography. There is no real fundamental difference in the principle of UPLC and …

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IR Do’s And Don’ts In Pharmaceuticals

IR Do’s And Don’ts In Pharmaceuticals: Do’s of IR: Whenever any error massage is displayed on the monitors, immediately inform to instrumentation engineer. Example: error massage displayed as a ” …

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Computer system validation (CSV) as per FDA

What is Computer system validation? Food and Drug Administration (FDA) guidelines for software validation outlines general validation principles applicable to medical device software or software used to design, develop, or …

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Calibration of Osmometer in Pharma

Calibration Of Osmometer: 3 point calibration of Osmometer: Turn on the main power supply and then switch on the instrument by using “on/off” switch. Go to measure on display and …

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Swiss Garnier multiple openings on phone call interview

Swiss Garnier multiple openings: Phone call Interview for QC/ QA/ Production/ Packing/ Maintenance/ PPIC/ IT departments. Location: Sikkim Departments: QC/ QA/ Production/ Packing/ Maintenance/ PPIC/ IT Position: Operator/Executive/Technician/Asst. Manager/Manager Experience: …

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Endo India Par Formulations openings-apply now

Endo India Par Formulations Openings for Multiple departments: Endo India Par Formulation Opening for manufacturing/QA/QC/Warehouse/Stability/Packing Job Location: Chennai Department: Manufacturing/QA/QC/Warehouse/Stability/Packing Position: Analyst/Sr.Analyst/Associate/Sr.Associate/Technical Assistant Experience: 02-12 yrs Qualification: B.Sc/M.Sc/D.Pharma/B.Pharma/M.pharma/ITI/Diploma Kindly share …

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Gland Pharma Ltd-Walk-Ins On 28th & 29th Dec’ 2021

Gland Pharma Ltd-Walk-Ins for Production, Micro and IPQA For Production: Department: Production Position: Chemist/Compounding/Autoclave operators Experience: 2-5 yrs Qualification: B.Sc./B.Pharma/M.Sc/M.pharma Sterile injectable experience is mandatory. For IPQA: Department: IPQA Position: …

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Modern periodic table of elements

Periodic Table Of Elements: The periodic table, also known as the periodic table of chemical elements, represents the chemical elements in tabular form. The periodic table is widely used in …

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What are the Checkpoints of OOS investigation?

What are the Checkpoints Of OOS Investigation? A laboratory test, which is required by CGMP regulations (§§211.160 and 211.165), is required to ensure that components, containers and closures, in-process materials, …

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Impurities in Drug Substances as per IP in pharma

Impurities In Drug Substances: Impurities fall into one or more of the following categories: Inorganic Impurities Organic Impurities Residual solvent Inorganic Impurities in drug substances: Inorganic impurity usually results from …

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8 sonicator’s possible errors in pharma?

Sonicator’s Possible Errors and action plans in Pharma: Sonicator’s Possible errors: Addition of more diluent may cause for improper mixing of the solution. Addition of less diluent may cause for …

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Calibration of Rotary shaker in pharma

Calibration Of Rotary Shaker There are two parameter for calibration of rotary shaker: 1. Timer calibration and 2. Verification of RPM Timer Calibration: Set the timer for 10 mins. Press …

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pH meter do’s and don’ts in pharma

PH Meter Do’s And Don’ts: pH meter do’s and don’ts are the preventive measure for the instrument to sustain the pH meter in good condition. pH Meter Do’s: Before measure, …

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Operation and calibration of Muffle Furnace

Operation And Calibration Of Muffle Furnace in pharma: Objective: To lay down a procedure for operation and calibration of muffle furnace. Scope: The standard operating procedure covers the operation and …

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Calibration of DUSA Shaker in pharma

Dusa shaker instrument is used in the analysis of Metered Dose Inhaler (MDI). The instrument which is used in the pharmaceutical industry should be calibrated to get proper and consistent …

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What are the 4 Types of Column Chromatography?

Before understanding the types of column chromatography, need to understand what is column chromatography? What is Column Chromatography? In column chromatography, the stationary phase is solid, and the mobile phase …

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What is validation in pharmaceutical industry?

Validation is the most important activity in the pharmaceutical industry. There are multiple types of validation in the pharmaceutical, such as Analytical Method Validation, Process Validation, Cleaning Validation, Equipment Validation, …

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HPLC Calibration Parameters in pharma

HPLC Calibration Parameters: There are a total 9 parameters for HPLC calibration, these are as follows; These are all calibration parameters performed while calibration. HPLC Calibration Parameters Acceptance Criteria: The …

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Good Documentation Practices Dos and Donts

Good Documentation Practices Dos and Donts (GDP): Good Documentation Practices (GDP) Do’s: Use the defined colored ball pen for document entry. Use the defined date and time format. Make document …

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Karl Fischer Titration Methods in pharma

Karl Fischer Titration Methods: Karl Fischer titrations use volumetric or coulometric titrations to assess the amount of water in a sample by oxidizing sulfur dioxide with iodine in a buffer …

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What are the 4 types of tablets in pharma?

The term “pharmaceutical tablet” refers to both molded and pressed unit dosage forms of medications that contain one or more active medicinal ingredients. Typically, a tablet consists of a combination …

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What is a Deviation in pharmaceuticals?

What is a Deviation in pharmaceuticals? Managing deviations is one of the most important aspects of pharmaceutical manufacturing. Defining deviation as a departure from written instructions, if there are no …

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25+ Interview Questions on Polarimeter?

Polarimetric methods are reliable and simple methods for determining and analyzing the structure of expensive and nonreplicable samples in macro, semi-micro, and microanalysis. Pharmaceutical, chemical, essential oil, flavor, and food …

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Definition of ALCOA Plus

Definition of ALCOA Plus: 1. A-Attributable: Attributable means recording who performed an action and when. And, if a record is changed, who did that and why. 2. L-Legible: Legible means …

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What are GAMP 5 Software Categories?

What are GAMP 5 software categories? There are 5 software categories as per the International Society for Pharmaceutical Engineering (ISPE).  In GAMP 4 there were 5 software categories but in …

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Principle of Turbidity in pharma

Principle of Turbidity in pharma Turbidity is the optical property, that causes light to be scattered and absorbed, rather than transmitted. The scattering of the light that passes through a …

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10 Method Validation Parameters in Pharma

Method Validation Parameters in Pharma Analytical Method validation is an essential step in the development of reference methods and in the assessment of a lab’s ability to produce reliable analytical …

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Micro Labs Ltd Walk-in-interview on 6th March 2021

Micro Labs Ltd Walk-In-Interview for Production and stores department. Micro labs Location: Bangalore Position: Officer/Executive/Sr.Executive/Asst. manager for Production Qualification: B.Pharma / M. Pharma/ M.sc /B.Sc Experience: 2-8 yrs Position: Technical …

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What is an audit trail in pharma?

What is an audit trail in pharma? Why audit trail is required? Does audit trail in pharma is a regulatory requirement? What if the audit trail not performed? Who can …

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Best Information of X-Ray Diffraction

X-Ray Diffraction what it is? Does X-Ray Diffraction is a good technique for the identification of material structure? X-Ray Diffraction machine   Today we are in the 21st century and …

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