Testing Methods

Jan292023 by KBS.No Comments

Product Processes and Quality of In Process Material

Quality Control, General Topics, SOPs, Testing Methods

The purpose of a Product Processes and Quality of In Process Material system is to provide staff and management with objective insight into the process and related work products. Your process and product quality approach supports the delivery of high-quality products by providing project staff and managers at all levels with appropriate visibility into the process and related work products throughout the life of the pharmaceuticals. Product Processes and Quality of In Process Material Objective:- To ensure compliance of Product Processes and quality of in process material. Responsibility:- Section Supervisor Production Manager QA Incharge Procedure:- Issuance of Raw Material & Packaging Components Check the product name, strength, printing quality and quantity o...

Jan262023 by KBS.No Comments

Zinc Oxide Testing by Alternate Method

Testing Methods

USP is updating the General Chapter Zinc Oxide Testing by Alternate Method Determination of the monograph to include ion chromatography as a method for the assay. Zinc oxide is used in various skin care creams, drugs, and drug products. The ion chromatography analysis involves the separation of zinc followed by a post-column reaction using 4-(2-pyridylazo) resorcinol (PAR) reagent and subsequent detection at 530 nm wavelength. Sample preparation consisted of 0.1868 g of sample dissolved in 10 mL 6 mol/L HCl and made up to 100 mL with ultrapure water. PURPOSE This Raw material Specification & Analysis prescribes the requirements for Zinc Oxide Testing by Alternate Method, which is one of the components of a Capsule, tablet, and AX tablet. SCOPE It is applicable in the Material, Pr...

Jan262023 by KBS.No Comments

Meloxicam 7.5mg Injection Testing by UV Method and In House Method

Testing Methods

Meloxicam testing by UV method and In House method 2, meloxicam is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by the breakdown of the joint lining) and rheumatoid arthritis (arthritis caused by inflammation of the joint lining) Meloxicam 7.5mg Injection Testing by UV Method and In House Method is also used to relieve pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. . Meloxicam is in a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking the body's production of substances that cause pain, fever, and inflammation. PURPOSE To describe the operational procedure Meloxicam 7.5mg In...

Mar52022 by KBS.No Comments

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...

Mar52022 by KBS.No Comments

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...

Mar52022 by KBS.No Comments

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...

Mar52022 by KBS.No Comments

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...

Feb252022 by KBS.No Comments

Dextromethorphan Hydrobromide Raw Material Testing

Testing Methods, Raw Material

Dextromethorphan Hydrobromide Raw Material Testing specification & analysis prescribes the requirements with IR spectrum and Alternate Method of Analysis on UV System and Other Testing procedures. Dextromethorphan Hydrobromide Raw Material Testing PURPOSE This raw material specification & analysis prescribes the requirements Dextromethorphan Hydrobromide Raw Material Testing which is used in Syrup & Tablet. 1.0 PURPOSE This raw material specification & analysis prescribes the requirements for Dextromethorphan Hydrobromide which is one of the components of Syrup & Tablet. 2.0 SCOPE It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 3.0 REFERENCES USP/BP 4.0 DE...

Feb252022 by KBS.No Comments

Deionized Water Testing Procedure

Testing Methods, Raw Material

Deionized Water Testing Procedure Raw Material specification & analysis prescribes the requirements with and Other Testing procedures. Deionized Water Testing Procedure for Raw Material PURPOSE Deionized Water Testing Procedure PURPOSE This raw material specification & analysis prescribes the requirements for De-ionized water, which is used in different pharmaceutical preparations. SCOPE It is applicable for the analysis of Do-ionized water manufactured in water treatment section. REFERENCES In-house DEFINITIONS Follow SOP determination Pharmaegg.com SPECIFICATIONS In-house PHYSICAL ANALYSIS TESTS SPECIFICATIONS 1. Physical Form Liquid 2. Colour Colourless 3. pH Between 5.0 to 7.0 at 30°C 4. Conductivity Should not be more than 1.4µS/cm at 30°C CHEMICAL ANALYSIS ...

Feb252022 by KBS.No Comments

How to Test Cloxacillin Sodium

General Topics, Raw Material, Testing Methods

How To Test Cloxacillin Sodium Raw Material specification & analysis prescribes the requirements with IR spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. How To Test Cloxacillin Sodium Raw Material PURPOSE This raw material specification & analysis prescribes the requirements for How To Test Cloxacillin Sodium Raw Material which is used in Capsules. PURPOSE This raw material specification & analysis prescribes the requirements for Cloxacillin Sodium (Compacted) which is one of the component of Capsule. SCOPE It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. REFERENCES USP/BP/Inhouse DEFINITIONS Follow SOP pharmaegg.com SPECI...