Chapter 1: Introduction
1.1 Nature of the Dissertation
Identification, quantification and analysis Amoxicillin and Flucloxacillin Sugar free antibiotics which are manufactured at Athlone Laboratories by high liquid fluid chromatography (HPLC).
The project also involves Method Transfer validation by analysis Amoxicillin Sugar Free for the new project of GSK Mayenne France, this involved Identification, quantification and analysis of carrying Amoxicillin Trihydrate API and Sodium Benzoate in Amoxicillin Sugar Free antibiotics.
1.2 Scope
Analytical Testing is carried to identify and quantify the API, excipients and related substances in a drug. Since most drugs are exhibit UV absorbances, HPLC with UV detection is commonly used in assays for …show more content…
It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production; from the starting materials and equipment to training of staff. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process (WHO, 2006).
1.5 Analytical Method Validation
Analytical test demonstrates that an analytical procedure is suitable for its intended use (FDA, 2014); this is achieved by testing a number of validation characteristics (McPolin, 2009).
1.5.1 Typical characteristics include:
• Limit of Quantitation
• Limit of Detection
• Linearity
• Accuracy
• Precision (repeatability, intermediate precision, reproducibility)
• …show more content…
It affects column efficiency and back pressure. The efficiency of the column decreases as particle size increases so there is poorer peak separation. However, the flow resistance of the column also decreases with large particle size which means that the back pressure decreases. The most popular particle size for analytical columns is 5μm.
2.4.6 Pore size and surface area of support materials
Packings with a large pore size have small surface area whereas small pore size have a large surface area. Column material with a small pore size 5000 Resolution of Active and Sodium Benzoate should be ≥8.0
Accuracy Standard accuracy should be between 98-102%
Standard drift should be < 25 0C. 2 ml of Sodium Benzoate stock solution was added to each standard then made to the mark with deionised water. The standards were then filtered into sample vials using a 0.45um.
Reconstitution of Samples
Weight of the powder was obtained first. The weight of powder + bottle was obtained. The 125mg/5ml sample were reconstituted with 84ml and 250mg/5ml of with 60ml of deionised water as per instruction. The sample was mixed thoroughly and weight of reconstituted bottle was
1.1 Nature of the Dissertation
Identification, quantification and analysis Amoxicillin and Flucloxacillin Sugar free antibiotics which are manufactured at Athlone Laboratories by high liquid fluid chromatography (HPLC).
The project also involves Method Transfer validation by analysis Amoxicillin Sugar Free for the new project of GSK Mayenne France, this involved Identification, quantification and analysis of carrying Amoxicillin Trihydrate API and Sodium Benzoate in Amoxicillin Sugar Free antibiotics.
1.2 Scope
Analytical Testing is carried to identify and quantify the API, excipients and related substances in a drug. Since most drugs are exhibit UV absorbances, HPLC with UV detection is commonly used in assays for …show more content…
It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production; from the starting materials and equipment to training of staff. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process (WHO, 2006).
1.5 Analytical Method Validation
Analytical test demonstrates that an analytical procedure is suitable for its intended use (FDA, 2014); this is achieved by testing a number of validation characteristics (McPolin, 2009).
1.5.1 Typical characteristics include:
• Limit of Quantitation
• Limit of Detection
• Linearity
• Accuracy
• Precision (repeatability, intermediate precision, reproducibility)
• …show more content…
It affects column efficiency and back pressure. The efficiency of the column decreases as particle size increases so there is poorer peak separation. However, the flow resistance of the column also decreases with large particle size which means that the back pressure decreases. The most popular particle size for analytical columns is 5μm.
2.4.6 Pore size and surface area of support materials
Packings with a large pore size have small surface area whereas small pore size have a large surface area. Column material with a small pore size 5000 Resolution of Active and Sodium Benzoate should be ≥8.0
Accuracy Standard accuracy should be between 98-102%
Standard drift should be < 25 0C. 2 ml of Sodium Benzoate stock solution was added to each standard then made to the mark with deionised water. The standards were then filtered into sample vials using a 0.45um.
Reconstitution of Samples
Weight of the powder was obtained first. The weight of powder + bottle was obtained. The 125mg/5ml sample were reconstituted with 84ml and 250mg/5ml of with 60ml of deionised water as per instruction. The sample was mixed thoroughly and weight of reconstituted bottle was