ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To lay down the procedure for calibration of High-performance liquid chromatography.

2.0 SCOPE: 

This procedure is applicable to the calibration of High-Performance liquid chromatography and the LC Solution for HPLC used in Quality Control laboratory.

5.0 PROCEDURE:

5.1 Calibration of pump:

5.1.1 Ensure that the pump is switched ON.

5.1.2 Fill the mobile phase reservoir with distilled water filtered using 0.2 micron filter.

5.1.3 Put ‘ON’ the pump by depressing ON/OFF key.

5.1.4 Set the flow rate of 0.5 ml, 1.0ml, 1.5ml, 2.0ml for 10 minutes in all the four ports (Port A, Port B, Port C, Port D)

5.1.5 Collect the discharged volume of water from the out let of the pump for 10 minutes from using a clean, pre-weighed measuring cylinder.

5.1.6 Weigh the measuring cylinder and note down the weigh. Check the observed weight against the expected weight. (1 ml of water = 0.99602 g) at 25° c.

5.1.7 Record the observed weights in to calibration record, as per annexure-2

5.1.8 Acceptance criteria: Observed weights should not deviate by more than +/- 0.1% of expected weights.

5.2 Calibration of detector:

5.2.1 Calibration of wavelength accuracy of caffeine:

5.2.2 Preparation of test solution: Weigh accurately about 25 mg of anhydrous caffeine WS into a 100ml volumetric flask, dissolve and dilute to volume with water.  Dilute 10 ml of the solution to 100ml with water to obtain a test solution containing 25mcg / ml of anhydrous caffeine.

5.2.3 Preparation of mobile phase: Mix 50 volumes of acetonitrile HPLC and 50 volumes of filtered distilled water and sonicate.

5.2.4 Testing procedure:

5.2.4.1 Set the flow rate 1.0 ml / min.

5.2.4.2 Set the detection wavelength to 270nm and set injection volume 20ml of test solution. Record the response of the major peaks.

5.2.4.3 Repeat the above step and record the responses in different wavelength i.e 270 nm, 271nm, 272nm, 273nm, 274nm, 275nm, 276nm, 277nm, 278nm, 279nm and 280nm.Check the area of each peak.

5.2.4.4 The peak obtained in the wavelength range of 274 to 278nm should show maximum  make necessary entries in the calibration record, as per annexure-1.

5.2.5 Wavelength accuracy:

5.2.5.1 The test is automatically executed by LC software, and results are displayed.

5.2.5.2 Acceptance criteria:  Wavelength - NMT 1 nm, D2 lamp energy - > 800.

5.3 Calibration of detector:

5.3.1 Linearity check:

5.3.1.1 Preparation of test solution: Weigh accurately about 50mg of anhydrous caffeine WS into a 100ml volumetric flask, dissolve and dilute to volume with water - Solution (A).

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1.0 PURPOSE

To lay down procedure for operation of fume hood.

2.0 SCOPE: 

This procedure is applicable for fume hood at Quality Control Laboratory.

5.0 PROCEDURE:

5.1 Daily monitoring:

5.1.1 Check the area for the cleanliness before using the fume hood. Get it cleaned if not cleaned.

5.1.2 Switch "ON" the fume hood

5.1.3 Switch "ON" the light

5.1.4 Check whether the exhaust fan and drainage system is working by switching “ON” exhaust and running the exhaust and running tap water respectively wherever applicable every day and record the observation in daily performance record, as per annexure-1.

5.1.5 If exhaust fan or drainage system is not working, inform the F&E to correct and fix under “maintenance “label.

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1.0 PURPOSE

To lay down a procedure for operation and calibration of Digital Automatic Karl Fischer Moisture Analyzer.

2.0 SCOPE: 

This procedure is applicable for operation and calibration of Digital Automatic Karl Fischer Moisture Analyser in the Quality control department.

5.0 PROCEDURE:

5.1 Pre start up     

5.1.1 Ensure that instrument is clean and reservoirs and beakers free from moisture.

5.1.2 Add Karl Fischer reagent to moisture free reservoir bottle fitted with an adaptor (Left hand side reservoir).

5.1.3 Remove large rubber cork and add some Karl fischer grade methanol to the moisture free beaker such that the metal wires of sensors are fully immersed. Replace cork immediately.

5.1.4 Connect the leads of the Pt-sensors to the sockets provided on the instrument.

5.1.5 Connect the titrator to mains supply and put the mains switch ON.

5.1.6 Adjust the speed of magnetic stirrer using the stirrer knob and the height of the sensor wires so that the magnetic stirrer does not hit them while rotating.

5.2 Operation

5.2.1 Neutralization of Methanol added to moisture beaker as solvent

5.2.2 Press the START key. Display shows the set stirring time, the end of stirring and the progress of titration at  respective intervals.

5.2.3 Listen for audio signal for end of titration. K/F reagent reading displays.

5.2.4 Follow 5.2.1 two to three times to make titration vessel moisture free

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1.0 PURPOSE

To lay down a procedure for operation and calibration of Dissolution test Apparatus.

2.0 SCOPE: 

This procedure includes the operation and calibration of Dissolution test apparatus in the quality control department.

5.0 PROCEDURE:

5.1 Operating Procedure:

5.1.1 Ensure the tank is filled with dissolution medium up to the mark in the tank.

5.1.2 Switch” ON” the mains. Switch “ON” the instrument, Heater and the pump.

5.2 Setting Temperature: 

5.2.1 Press SET “TEMP” key in the display.

5.2.2 Press 3, 7, 5 keys on the panel to set the required temperature (the required temp to dissolution vessel is 37 °C±0.5°C).

5.2.3 Press” ENTER” Key

5.3 Setting of RPM:

5.3.1 Press” SET RPM” key

5.3.2 Adjust the required” RPM “by pressing numbers required on the panel either (050,075,100).

5.3.1 Press “ENTER” Key

5.3 Setting of Time

5.3.1 Press “TEST TIME” key

5.3.2 Set the times by using the numbers required on the panel

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