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Montelukast Sodium Testing Procedure

Montelukast Sodium Testing Procedure

Testing Methods, Raw Material, SOPs
Montelukast Sodium Testing Procedure and Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Characters Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white crystalline powder and determination. Solubility (i) Take approximately 0.5 gram of sample into a clean test tube containing water. Close the test tube with stopper and shake well. The sample slightly soluble in water. (ii) Take approximately 0.5 gram of sample into a clean test tube containing alcohol. Close the test tube with stopper and shake well. The sample slightly soluble in alcohol. (iii) Take approximately 0.5 gram of sample into a clean tes...
How To Test Naproxen Sodium Raw Material

How To Test Naproxen Sodium Raw Material

Testing Methods, Raw Material, SOPs
How To Test Naproxen Sodium Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Characters How To Test Naproxen Sodium Raw Material Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white to creamy crystalline powder Solubility Soluble in water and in methanol; sparingly soluble in alcohol; very slightly soluble in acetone; and practically insoluble in chloroform and in toluene. Melting point Melts at about 225 °C with determination decomposition Procedure: Grind the Naproxen Sodium sample into a fine powder in a mortar and pack the capillary tube with sample by tapping on a hard surface so as to form a...
Paracetamol Raw Material Testing By UV Method

Paracetamol Raw Material Testing By UV Method

Testing Methods, Raw Material, SOPs
Paracetamol Raw Material Testing By UV Method specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Paracetamol Raw Material Testing By UV and Purpose This raw material specification & analysis prescribes the requirements for Paracetamol raw material Testing UV and HPLC Method. Characters Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, determination it should be white, crystalline powder. Solubility Sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Identification Melting point:- 168 °C to 172 °C Procedure: Paracetamol Raw Material Testing By UV Method, Grind the Paracetamol s...
Ranitidine HCl Testing UV and HPLC Method

Ranitidine HCl Testing UV and HPLC Method

Testing Methods, Raw Material, SOPs
Ranitidine HCl Testing UV and HPLC Method Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Ranitidine HCl Testing UV and HPLC Method and Purpose This raw material specification & analysis prescribes the requirements for Ranitidine HCl raw material Testing UV and HPLC Method. Characters Ranitidine HCl Testing UV and HPLC Method is spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white to pale yellow, crystalline, practically odorless powder. Is sensitive to light and moisture. Melts at about 140º, with decomposition. Solubility Ranitidine HCl Very soluble in water; sparingly soluble in alcohol. Melt...
Maintaining Machine Usage Log

Maintaining Machine Usage Log

Production
The Standard Operating Procedure of Maintaining Machine Usage Log is described in this post. Maintaining Machine Usage Log OBJECTIVE 1.1 To lay down the procedure for maintaining machine or equipment usage log. SCOPE 2.1 The scope of this SOP pertains to maintaining machine usage log of all machines or equipments placed in Production or Quality Area. RESPONSIBILITIES 3.1 It is the responsibility of Operator and section Supervisor to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist, Quality Control Analyst and Quality Assurance Officer to ensure that this SOP is followed as it is written. 3.3 It is the responsibility of Production Manager to make certain that this SOP is followed in its entirety, reviewed and updated as necessary. DEFINITI...
Operation Of Paste Cooking Kettle

Operation Of Paste Cooking Kettle

Production
In this post procedure of operation Of Paste Cooking Kettle is describe as given below Operation Of Paste Cooking Kettle OBJECTIVE 1.1 To describe procedures for the operation of Steam Jacket Kettle. SCOPE 2.1 This SOP applies to the operational procedure of Steam Jacket Kettle. RESPONSIBILITIES 3.1 It is the responsibility of steam jacket kettle Supervisor (Liquid manufacturing) to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (Oral Liquids), to ensure that this SOP is followed as it is written. 3.3 It is the responsibility of Senior Production Manager to make certain that this SOP is followed in its entirety, review and update as necessary. DEFINITIONS& ABBREVIATIONS NA MATERIALS & EQUIPMENTS NA PROCEDURE 6.1 Open the dr...
Cleaning Of Paste Cooking Kettle

Cleaning Of Paste Cooking Kettle

Production
Cleaning Of Paste Cooking Kettle is fully described in this post which helps you to clean the kettle. Cooking kettle is widely used in Pharmaceuticals industry so If you're going to be a part of Pharma then you should read this knowledge-based article about Cleaning Of Paste Cooking Kettle/ Cleaning Of Paste Cooking Kettle OBJECTIVE 1.1 To describe procedures for the cleaning of paste cooking Kettle. SCOPE 2.1 This SOP is applicable for the cleaning of the paste cooking Kettle in the tablet Section in the Production Department. RESPONSIBILITIES 3.1 It is the responsibility of section Supervisor to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (tablet section) to ensure that this SOP is followed as it is written. 3.3 It is the responsibi...
Training in Pharmaceuticals Industries

Training in Pharmaceuticals Industries

Production
In this post the complete detail is given about Training in Pharmaceuticals Industries, which help to personnel work-friendly in the pharmaceuticals industry. Training in Pharmaceuticals Industries OBJECTIVE 1.1. The purpose of this SOP is to describe the procedure for Training in Pharmaceuticals Industries of the personnel working under cGMP environment at Pharmaceutical. SCOPE 2.1. The scope of this Training in Pharmaceuticals Industries SOP pertains to all the persons working at Pharmaceutical. RESPONSIBILITY 3.1. It is the responsibility of departmental heads to follow this SOP as it is written. 3.2. It is the responsibility of QA to ensure that all employees have been trained and qualified in their respective job functions, regulatory and compliance procedures and safety regula...

Destruction Of Expired and Rejected Material

Production
Destruction Of Expired and Rejected Material SOP is described in this blogpost. PURPOSE: This procedure is established to destroy Expired Raw Materials, Expired & Rejected Returned Stock, Rejected In-process products, Rejected Packaging Components and obsolete records & documents. Responsibility: Warehouse Incharge, QC/QA Manager, Plant Manager and Chief Executive Officer. Procedure: Destruction is to be carried out semiannually preferably in the month of January & July of every year or when ever required. Segregate and Collected the Items as under:- 1. All rejected Raw Material (Active & non Active. 2. All Rejected inprocess products batches. 3. All Returned and Rejected Finished Stock from market & production. 4. All Rejected Packaging Components and o...

Returned Goods Handling

Production
Returned Goods Handling is described in this blogpost that help to handle of return goods OBJECTIVE: To describe the procedure for returned goods received from distributors/market. PROCEDURE: i) Returned goods received from Distributors will be received on a document. ii) This stock will be sorted out and segregated into 4 categories Category No.1 Stock can be reused if having reasonable shelf life at least more than six months after checking from Q.C. and redressing if required. Category No.2 If left over shelf life is between 3-6 months it will be converted to Physician sample after Q.C. checking. Category No.3 If the shelf life is below three months, it can be donated to any running clinic, or charity organization after checking from Q.C. and redressing if required, with fina...