Power point slide on analysis of astomocil

It shows the physical and chemical properties of astomocil. Laboratory procedures and parameters checked for

1. AN ORAL PRESENTATION ON STUDENTS’ INDUSTRIAL WORK EXPERIENCE SCHEME (SIWES)   UNDERTAKEN AT: SAM ACE PHARMACEUTICAL LIMITED KM 14 GBONGAN/IBADAN ROAD, AKODA EDE, OSUN STATE   BY: ADESHINA OLAJUMOKE OMOLARA MATRIC NO: 1909002027  DEPARTMENT OF CHEMISTRY, FACULTY OF SCIENCES, EKITI STATE UNIVERSITY, (EKSU), ADO-EKITI. 1

2. PRODUCTION DEPARTMENT PROCESS FLOW Dispensary Section: This is the gateway for all the raw materials used in the production department, they normally carry out weighing and dispensing of all raw materials with the aid of electronic weighing balance as specified in the Manufacturing Order (M.O) and batch operation. Mixing Area: This is where the active ingredients and some excipients are mixed together. The raw materials dispensed in the dispensing drum is placed on the mixer and allowed to mix for 30minutes. Filling and Capping Section: This is where the mixed dry powder drugs (antibiotics) are filled into syrup bottles that serve as the oral suspension and also filling of gelatine shell serving as capsule product. Also, in this section, capping of filled syrup bottles is done. 2

3. QUALITY CONTROL ASSURANCE (QCA) The Quality Control Assurance is concerned with the analysis of raw material, bulk and finished products to ensure the safety of the drugs. It is divided into two departments, which are; MICROBIOLOGY LABORATORY CHEMISTRY LABORATORY 3

4. CHEMISTRY LABORATORY This is the laboratory in which chemical analysis and physical test are done on raw materials and finished products using instrument of high precision and accuracy. The work done in this department are; Chemical analysis which include; Iodometry titration analysis Physical analysis which include; PH test, Relative density test, Viscosity Test Dozing Appearance Test Conductivity Test 4

5. CHEMICAL AND PHYSICAL ANALYSIS ON ASTAMOCIL 60ml 5

6. CHEMICAL ANALYSIS IODOMETRIC TITRATION Test: Iodometric titration is used for validation process and maintaining the accuracy of measurement of the substance itself in order to prevent obvious errors that should not occur in pharmaceutical field. AIM: To test for the potency of amoxicillin trihydrate content in the Astamocil 60ml dry suspension. APPARATUS: Pipette, burette beaker, conical flask, cork, retort stand, stirrer rod, spatula and weighing balance. REAGENTS: sodium thiosulphate, hydrochloric acid , sodium hydroxide, iodine and starch. 6

7. PROCEDURES (Firstly for the blank of the raw materials) Weigh 1.67g of amoxicillin trihydrate in a beaker, Add 100 ml of distilled water, Pipette 2ml out of the solution, Add 10 ml of iodine and few drops of indicator(starch), Titrate against sodium thiosulphate and observe the colour change. It changed from blue black to light blue or colourless and record the value. 7

8. PROCEDURES (For the sample) Pipette 2 ml of sample, Add 2 ml NAOH then close it and leave for 15 minutes, Then add 2ml of HCL and 10 ml of iodine solution, Close it tightly to avoid escape and leave for another 15 minutes, Add few drops of indicator and titrate against sodium thiosulphate and record the value when colour change occur. 8

9. RESULT Calculate the difference (blank value – sample value). Specification range is from 3.2 to 4.8. Percentage Potency of the sample : 99.96/ working standard (4.2) x difference (blank value – sample value) 99.96/4.2 x difference SPECIFICATION : 92.5 -107.5 % 9

10. PHYSICAL ANALYSIS ANALYSIS SAMPLE TYPE SAMPLE PREPARATION RESULTS 1. PH Meter Test Finished Product (FP) and Bulk product Weigh 20g of the sample and dissolve it in 40ml of distilled water. The measurement for this is 2:1 (the sample should be 2x of the water used). The Specification ranges from; 4 – 7. 2. Weight per mil (W/mil) Finished Product (FP) and Bulk product Dissolve 20g of the sample inside 40ml of distilled water and weigh accurately. Cal= weight of sample weight of water 1.09 – 1.14 (g/ml). 3. Appearance Test Bulk and Finished products Weigh 10g of the sample inside a beaker and measure 20ml of distilled water using a measuring cylinder. Observe the colour formed. Baby Pink 10

11. CONCLUSION In summary, my student’s industrial work experience scheme in Sam Ace limited has exposed me to various modes of analysis, both chemically and microbiologically. I was also able to hit into the wealth of experience of my supervisors in all aspects of drug production which include the antibiotic section and non antibiotics section, starting from the raw materials sampling to the certification of finished products. I was able to do proper documentation for each experiments done because it will be of waste if all experiment is not documented. 11