Sunday, June 20, 2021

Analytical Method of Medicinal Product Starting Generic Name with word “A”

Assay Method of Aceclofenac Tablet Solvent Methanol Standard 50 mg ----® 100 ml ----® take 2 ml ----® 50 ml  (Shake 30 minutes) Sample Same as standard. Take absorbance at 276 nm.   Assay Method of Albendazole Tablet Sample Dissolve powdered...

Changes to USP 38 General Chapter 791 pH

Changes to USP 38 <791> pH in USP 39 1S 1.0 The word “Standardization”has been replaced with the word “Calibration” 2.0 The word“read” has been changed with the word “Record” 3.0...

Significant Change in Pharmaceutical Stability Testing

Significant change for a drug substance is defined as failure to meet its specification during stability testing. Stability of a pharmaceutical product may be defined as the capability...

SOP on Validation of Microsoft Excel Calculations Worksheets

1.0 Objective To lay down a procedure for validation of Microsoft Excel worksheets to be used for analytical calculations. 2.0 Scope This SOP is applicable for validation...

SOP on Stability Studies for Drug Products

1.0 Objective: To lay down a procedure for carrying out stability studies of drug products. 2.0 Scope: This SOP is applicable for carrying out stability studies of...

SOP for Behavior in Quality Control Department

1.0 Objective To lay down a procedure for behavior in quality control department. 2.0 Scope This SOP is applicable to all persons working in Quality Control department. 3.0...

Sampling, Preservation and Storage Procedure of Water Sample  

1.0 Objective To lay down a procedure for the Sampling, Preservation and Storage of water sample. 2.0 Scope This Standard Operating Procedure is applicable for Sampling, Preservation...

Sampling, Preservation and Storage of Water Sample

1.0 Objective To lay down a procedure for the Sampling, Preservation and Storage of water sample. 2.0 Scope This Standard Operating Procedure is applicable for Sampling, Preservation...

Preparation and Bio-Burden Monitoring of 70% IPA

1.0 Objective To lay down a procedure for the preparation and bio-burden monitoring of 70% IPA. 2.0 Scope This Standard Operating Procedure is applicable for preparation and...

List of ICH Quality Guidelines in Pharmaceuticals  

Revised ICH (International Conference on Hormonisation) Quality Guidelines in pharmaceuticals are given below:    Q1A (R2) - Stability Testing of New Drug Substances and Products Q1...