How Perform Limit Test for Heavy Metals (SOP)

Complete reagent preparation guide for LIMIT TEST FOR HEAVY METALS ( BP) - steps for preparation of acetate buffer pH 3.5, thioacetamide reagent, lead standard solutions, hydrochloric acid, ammonia, phenolphthalein.

Limit tests for heavy metals need not be confusing. This guide includes detailed protocols with equipment, reagent preparation and step-by-step instructions to perform a typical test procedure. For all of the Test A, B, C and D options, there are clear instructions to ensure your pharmaceutical quality control is accurate and on track. 1.0 Scope: … Read more

How to Perform Solubility Test

Infographic on solubility test procedure and guideline in pharmaceutical quality control; preparation of sample, choice of solvent, dissolution steps, solubility classification table, laboratory apparatus and reagents, and testing conditions.

The solubility test is a basic test performed in the pharmaceutical laboratory to assess the solubility of a substance in a given solvent. This guide describes the entire solubility testing procedure, apparatus used, considerations for selection of solvents, temperature, and standard solubility classification from very soluble to practically insoluble. This step-by-step reference will help you to test accurately and fulfil the pharmaceutical quality requirements.

Preparation and Standardization of 0.1M Ethanolic Sodium Hydroxide Solution SOP

Infographic for preparation and standardization of 0.1 M ethanolic sodium hydroxide solution with apparatus, reagents, steps, benzoic acid titration, calculation of molarity, and storage conditions.

This article describes the SOP for preparation and standardization of 0.1M ethanolic sodium hydroxide solution. It includes apparatus, reagents, preparation of the thymolphthalein indicator, preparation of sodium hydroxide solution, standardization procedure of benzoic acid, formula to calculate the molarity, storage conditions and reference as per IP norms. It is a guide for pharmaceutical quality control and analytical laboratories.

Laboratory Color Test Procedure: Step-by-Step Guide

Blue SOP file for laboratory color test procedure placed on a stainless steel table in a pharmaceutical QC laboratory

1.0 Scope: Procedure is applicable to perform the colour test of the sample wherever specified. Learn: Procedure to Check Clarity of Sample Solution 2.0 Apparatus:You will need: 3.0 Reagents:Use analytical grade (AR) chemicals for the following: 4.0 Method: A. Ferric Chloride Colorimetric Solution (FCS) Dissolve roughly 55 g of ferric chloride hexahydrate in a mixture … Read more

SOP for Cleaning of Vacuum Cleaner

Vacuum Cleaner Cleaning Record annexure used in pharmaceutical production department for documenting equipment cleaning activities and maintenance procedures.

1.0 OBJECTIVE: To lay down a procedure for cleaning of vacuum cleaner. 2.0 SCOPE: This procedure is applicable to cleaning of vacuum cleaner used in production department in the Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S):NA 5.0 PROCEDURE: 5.1 Ensure that the power supply is turned off.5.2 Transfer the … Read more

SOP for DM Water Plant (Operation and Maintenance)

Blue SOP file labeled “SOP for DM Water Plant (Operation and Maintenance)” placed on a stainless steel table inside a pharmaceutical production area, with blurred DM water plant equipment and a chemist working in the background

1.0 OBJECTIVE: To lay down the procedure for operation and maintenance of DM water plant. 2.0 SCOPE: This procedure applies to DM water plant in Pharmaceuticals. 3.0 RESPONSIBILITY: Production In-Charge, Maintenance personnel, Maintenance Engineer. Learn: SOP for Preventive Maintenance of DM Plant 4.0 PROCEDURE for DM Water Plant: 4.1 PLANT SPECIFICATIONS:Maximum flow rate: 1.2 m3 … Read more

SOP for Cleaning and Operation of Holding Tank (Capacity –3000 ltrs)

Blue SOP file labeled “SOP for Cleaning and Operation of Holding Tank (Capacity – 3000 ltrs)” placed on a stainless steel table in a pharma production area, with a chemist working near a large holding tank in the background.

1.0 OBJECTIVE: To lay down the procedure for cleaning and operation of holding tank(capacity –3000 ltrs). 2.0 SCOPE: This procedure is applicable for cleaning and operation of holding tank (capacity –3000 ltrs) in Liquid department Pharmaceuticals. 3.0 RESPONSIBILITY:Operator, officer, executive – Production departmentManager- Production Department 4.0 DEFINITION(S)NA 5.0 PROCEDURE for Cleaning and Operation of Holding … Read more

Change Control system SOP: Initiation, Review, Assessment, Format, Numbering, Approval and closing

Close-up of a blue SOP file on a stainless steel table in a pharmaceutical production area, labeled “Change Control System SOP; Initiation, Review, Assessment, Format, Numbering, Approval and Closing,” with a chemist’s gloved hands resting beside it and blurred equipment in the background.

Change Control system SOP, including preparation of Format, Numbering, Initiation, Change & Assessment by QA, Review, Approval, Implementation, Distribution, Retrieval, Annexures, and closing of change control. 1.0 OBJECTIVE: To lay down the procedure for Change Control system SOP. 2.0 SCOPE: This Change Control system SOP is applicable to all related user departments as specified in … Read more

SOP for Cleaning and operation of sparkle filter press

Image showing pharma production area, inside it, A stainless steel table and a blue labelled file. the text on file written is "SOP for Cleaning and operation of sparkle filter press".

1.0 OBJECTIVE: To lay down the procedure for Cleaning and operation of sparkle filter press. 2.0 SCOPE: This procedure is applicable for cleaning and operation of sparkle filter press in liquid department at Pharmaceuticals. 3.0 RESPONSIBILITYOperator, Officer, Executive- Production DepartmentOfficer, Executive- Quality Assurance DepartmentManager –Production and Quality Assurance Department. 4.0 DEFINITION(S)NA 5.0 PROCEDURE for Cleaning … Read more