PHRM lab 1 RAW Material Testing ON Excipient FROM USP 40N 35 PDF

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LAB REPORT 1 OF PHARMACEUTICAL LAB...

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EXPERIMENT 1 RAW MATERIAL TESTING SELECTED TESTS ON EXCIPIENTS FROM USP 40/NF 35

OBJECTIVE- The objective of the experiment is to analyze the potato starch raw materials with identification B, identification C, and pH tests and examining the results in accordance with USP monograph.

ACCEPTANCE CRITERIA1. Identification B - A thick, opalescent mucilage is formed on boiling the potato starch solution. 2. Identification C – An orange red to dark blue color is produced that disappears upon heating. 3. pH – 5.0 – 8.0 range.

OBSERVATIONSIdentification – B: 1. Aim- The test is performed to determine the presence of raw materials in potato starch based on USP monograph. 2. Sample acceptability- The test will pass if thick and opalescent mucilage is formed according to USP monograph. 3. Procedural changes – The top loading balance was used to weigh the potato starch instead of analytical balance and 1L beaker was used instead of 100ml due to reason that maybe we weighed the potato starch in grams instead of milligrams. 4. Observations- A thick mucous layered solution is formed upon boiling and then heating. And the test passed. 5. Deviations- None 6. Relative sources of error- The errors maybe in techniques of weighing or overheating.

Identification – C: 1. Aim- The test is performed tom observe the colour change from orange red to dark blue by adding 0.1 iodine and potassium iodide TS 2 indicator sample in the sample. 2. Sample acceptability- Orange red to dark blue colour is produced and it disappears on heating. 3. Procedural changes – None

4. Observations- The thick mucilage formed in identification B is added with 1 drop of iodine and potassium iodide TS2 and the former turns blue in colour which further disappears on heating. The test is passed according to USP monograph. 5. Deviations- None 6. Relative sources of error- The errors maybe in heating.

pH 1. 2. 3. 4. 5. 6.

Aim- To check the pH of the solution prepared. Sample acceptability- pH range between 5.0 to 8.0. Procedural changes – None Observations- The observed pH of the sample is 6.53 Deviations- None Relative sources of error- There were no errors observed while performing but it could be in calibrating the pH meter.

CERTIFICATE OF ANALYSIS- Attached with the lab report sheets. CONCLUSION – The all three tests for potato starch raw materials were passed according to the USP monograph.

LAB REPORT QUESTIONS1. The excipient is defined as the substance other than active pharmaceutical ingredient API that has been added intentionally in any pharmaceutical product for safety, long term stabilization, bulking, etc. 2. The excipients need to be tested to ensure the safety and purity of the drug. 3. The united states pharmacopeia includes the quality standards for medicines. These standards are used to ensure the safety, quality of medicines and their ingredients.

REFERENCEShttps://www.usp.org/about/public-policy/overview-of-monographs https://www.pharmaexcipients.com/pharmaceutical-excipients-some-definition/...