SOP for Measurement of Particle Size of Raw Materials Using Microscopic Method : Pharmaceutical Guidelines

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SOP for Measurement of Particle Size of Raw Materials Using Microscopic Method

Standard operating procedure to determine the particle size of Raw Material microscopically.

1.0 OBJECTIVE

To lay down the procedure for measurement of particle size of raw materials using the microscopic method.

2.0 SCOPE

To measure & count the particle & particle size of raw material by the visual microscopical method.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant (Q.C)/Executive
3.2 Checking: Executive / Astt. Manager (Q.C)

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Take approximately 100 mg powder in the clean dry test tube and add 10 ml of paraffin oil, vortex it for 30 seconds to make a uniform suspension.
5.2 Put one drop on clean, dry slide with the help of pipette. Put clean dry coverslip gently avoiding air bubbles.
5.3 Mount the slide in the microscope and put micrometer scale in the eyepiece and focus 10X or 40X or 100X as per requirement objective.
5.4 The measurement of micrometer scale for different objects as follows.
For 10X objective, 1 Division =10µ
For 40X objective, 1 Division =2.5µ
For 100X objective, 1 Division =1µ
5.5 Select 5 different microscopic field and measure a total of about 200 to 300 particles.
5.6 After the completion of the measurement, calculate the particle size and % particles of different particles size range as required.
5.7 The size limit and the permitted number or particles are as per individual specification.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 % - percentage
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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