Qualitative and Quantitative Analysis of Finshed Product: Aneta Pharmaceticals Pvt. LTD

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Qualitative and Quantitative Analysis of

Finshed Product

Aneta Pharmaceticals Pvt. Ltd.


Bhagat Komal (2205070400089)
Borad Parth (2205070400092)
Prajapati Khushi (2205070400036)
Vekariya Dhruvi (2205070400079)
Satawara Gayatri (2205070400053)
Guide Name: Dr. Urja Pandya​ ​
Department : M.Sc. Microbiology [SEM- Ⅳ]​
Institute : Institute of Science​
Introduction

The tests are designed primarily to determine


whether a substance or preparation complies with
an established specification for microbiological
quality.

 Levocetirizine Tablet
• Manufacturing of three validation batches.
Granulation

Lubrication

Compression Stage
Aim and Objective
Aim : A method using the number of unique bacteria that exist in only one sample and not in
other samples.

Objective : Raw Materials


Water Analysis
Finished Products
TYMC Test
TAMC Test
Sub-Culturing
Methodology
Microbial limit test is performed for the estimation of the number of viable microorganisms present
in sample.

[TYMC and TAMC test]


Methodology
Sub-culturing is a procedure of transferring of microorganism into fresh nutritive medium from
its stock culture.
Result

SDA Plate –Fungal growth SCDA Plate – Bacterial growth MCA Plate – E.coli

MSA – S.aureus CA Plate – P.aeruginosa XLDA Plate - Salmonella


Conclusion
Acceptance criteria for TAMC and TYMC are based on individual results. or on the average
of replicate counts when replicate counts. are performed by pour plate methods. Qualitative
and quantitative tests for Levocitrizine complies according to the acceptance criteria.

The pharmaceutical product for microbial limit test is complies as per the
pharmaceutical limit of microbial limit test.
Thank you!

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