Pharmaguddu

SOP on Withdrawal, Storage, Observation & Destruction of Control Sample

Published on: August 18, 2023 by Pankaj Dept. Quality control

Standard Operating Procedure on Withdrawal, Storage, Observation & Destruction of Control/Retention Sample in Pharmaceuticals. 1.0 Objective: This SOP applies to the withdrawal, storage, observation, and destruction of control samples from production (OSD & Injectable) and Quality control (R.M. Retention) in the pharmaceutical formulation plant. 2.0 Scope: This Standard Operating Procedure applies to the withdrawal, storage, … Read more

SOP on Receipt and Handling of Laboratory Samples

Published on: August 16, 2023 by Naresh Bhakar

1.0 OBJECTIVE: This procedure outlines the steps for receiving and Handling of Laboratory Samples. 2.0 SCOPE: This standard operating procedure pertains to the receipt and Handling of Laboratory Samples. 3.0 RESPONSIBILITY: The Quality Control Executive/Microbiologist is responsible for the implementation of this SOPThe Assistant Manager QC and/or QA Manager are responsible for Overall compliance with … Read more

SOP on Out of Acceptance Limit in Purified Water System

Published on: August 15, 2023 by Naresh Bhakar

OBJECTIVE: To establish a procedure for action to be taken where critical parameters exceed acceptable limits within the purified water system. SCOPE: This Standard Operating Procedure applies to the generation and distribution of purified water systems. RESPONSIBILITY: Officer, Executive – Engineering Department.Head – Engineering Department for overall compliance to this SOP. ACCOUNTABILITY:Head of Engineering PROCEDURE: … Read more

Pharmaceutical incompatibility – Types, Machanism, Intraction with Examples

Published on: August 13, 2023 by Naresh Bhakar

Pharmaceutical incompatibility is defined as any unwanted interaction of two or more drugs that results in a significant change either in the physical, chemical, or therapeutic behavior of drugs. The change can also result in an undesirable product which might affect the safety, efficacy, appearance, and stability of the product. Incompatibility can occur during compounding, … Read more

Pharmaceutical Suspension- Classification, Composition, Theory, Formulation, Evaluation, Advantages and Disadvantages

Published on: August 12, 2023 by Naresh Bhakar

Learn About Pharmaceutical Suspension- Classification, Composition, Theory, Formulation/Preparation, Evaluation, Types, Advantages, and Disadvantages. Definition: Pharmaceutical Suspension is a biphasic system that consists of solids finely dispersed into a liquid medium. It is a coarse dispersion in which the active ingredient as the internal phase is dispersed uniformly throughout the external phase with the help of … Read more

Preparation and Standardization of 0.1 M Disodium Edetate (EDTA)

Published on: August 10, 2023 by Naresh Bhakar

Name: How to Preparare and Standardization of 0.1 M Disodium Edetate (EDTA Ingredients : 1. Disodium Edetate. 2. Calcium Carbonate 3. Eriochrome black – T 4. Ammonia – Ammonium Chloride Buffer pH10 (Mix 5.4 grams of NH4Cl + 35 milliliters of 10M NH3 solution & dilute to 100 milliliters with water.) 5 Hydrochloric Acid. How … Read more

Design Qualification of Electric Stacker

Last Updated on: November 22, 2023 by Naresh Bhakar

1.0 OBJECTIVE: To design, engineer, and supply of Electric Stacker (Model: Modal name) and provide assurance that the machine is manufactured as per the URS and complies with CE recommendations. 2.0 SCOPE: The scope of this qualification document is limited to the Design Qualification of the Electric Stacker (Model: Modal name) for “Company Name and … Read more

SOP on Operation And Calibration Of Karl Fischer Apparatus

Published on: August 8, 2023 by Naresh Bhakar

Aim: To provide Procedure on Operation And Calibration Of Karl Fischer Apparatus.Objective: This standard operating procedure explains how to use and calibrate the Karl Fischer apparatus.Responsibility: Chemist/Executive Q.C. for following this procedure.Accountability: The Manager of Quality Control is accountable for overall compliance with this SOP. Procedure: Cleaning Related SOP: SOP for Analysis and Release of … Read more

SOP for Analysis and Release of Packing Materials

Published on: August 6, 2023 by Naresh Bhakar

1.0 Aim: Procedure for Analysis and Release of Packaging Materials 2.0 Purpose: This standard operating procedure outlines the procedure for analyzing and releasing packaging materials at [company name]. 3.0 Scope: This procedure applies to the quality control laboratory and covers the analysis and release of packaging materials. 4.0 Responsibility:QC Analyst: Responsible for analyzing packaging materials.QC … Read more

How can I Prepare and Standardization 0.5 M Sulfuric acid

Published on: August 5, 2023 by Pankaj Dept. Quality control

Aim: To prepare and standardize 0.5 M sulfuric acid (0.5 M H2SO4). Principle: 1. This is carried out by aqueous acid-base titration based on a neutralization reaction. 2. This titration takes place between sulphuric acid (H2SO4) and sodium carbonate (Na2CO3). 3. Sodium carbonate, anhydrous is a primary standard substance that reacts with a secondary standard … Read more

1.0 M Sulfuric Acid Solution- Preparation, Standardization, Reagents, Formula

Published on: August 3, 2023 by Pankaj Dept. Quality control

Objective: The purpose of this experiment is to standardize 1.0 M Sulfuric Acid. Materials used for 1.0 M Sulfuric Acid: Equipment: Beaker, Funnel, Pipette, BuretteChemicals: H2SO4, Phenolphthalein solution, and Anhydrous sodium carbonate. Theory: Methyl orange is commonly used as an indicator in titrations. In an alkaline solution, methyl orange appears yellow and has the following … Read more

0.1 M Sodium Hydroxide (NaOH), Preparation and Standardization

Published on: August 2, 2023 by Pankaj Dept. Quality control

Preparation and Standardization of 0.1 M Sodium Hydroxide (NaOH) in the Laboratory. Reagents: 1 Sodium hydroxide 2 Potassium hydrogen phthalate 3 Phenolphthalein solution. Chemical Reaction Principle: In this process, we will directly measure the strength of potassium hydrogen phthalate by using sodium hydroxide. To find the endpoint, we’ll use phenolphthalein as an indicator. Let’s understand … Read more

Preparation and Standardization of 1 M Sodium Hydroxide Solution (NaOH)

Published on: August 1, 2023 by Naresh Bhakar

In this experiment, we will focus on the preparation and standardization of a 1 M Sodium Hydroxide solution. Molarity and How to Prepare 1 M NaOH with Example: Example for factor calculation for standardization of 1 m NaOH:Na=23O=16H=1Total= 40 gm. Reagents Required for Preparation and Standardization of 1 M NaOH: 1 Sodium Hydroxide 2 Potassium … Read more

Preparation and Standardization of 1.0 M Hydrochloric Acid

Published on: July 31, 2023 by Pankaj Dept. Quality control

Name: Preparation and Standardization of 1.0 M Hydrochloric Acid in Pharmaceutical Laboratory. Reagents: Use the following reagents to prepare and Standardization of 1.0 M Hydrochloric Acid: 1 Hydrochloric Acid. 2 Anhydrous Sodium Carbonate 3 Methyl Red Method of Preparation of 1.0 M Hydrochloric Acid: To make 1.0 M hydrochloric acid, dilute 85.0 ml of concentrated … Read more

SOP for HPLC Column Cleaning and their Maintenance

Published on: July 30, 2023 by Naresh Bhakar

OBJECTIVE: To lay down a procedure for HPLC Column Cleaning and their Maintenance.SCOPE: This Standard operating procedure shall be applicable to HPLC Column Cleaning and maintenance of different types of HPLC columns used in the Quality Control Laboratory. RESPONSIBILITY: Officer/Execution QC department to follow this procedure.Manager QC department for overall compliance with this SOP. PROCEDURE … Read more

Extraction: Types and Different methods in Pharmaceutics

Published on: July 28, 2023 by Pankaj Dept. Quality control

Definition: “Extraction involves using a liquid solvent to remove active constituents from a solid or liquid substance. Or The separation of medicinally active portions of plant or animal tissues from the inactive or inert components by using selective solvents.” The extraction process has the following stages: Some important terms Menstruum– The solvent used for extraction … Read more