GLP about
Gas Chromatography, Dissolution, Atomic Adsorption Spectroscopy, Titration, pH
Meter and Conductivity meter
• Gas Chromatography
Ensure that the system is in calibrated state before use.
Before start of analysis ensure that the pressure of gases is
intact and there is no leak of gases.
Ensure that the molecular sieves and silica are
working properly.
Ensure the color of silica before start of
analysis.
Conditioning the column is to be done sufficiently before
starting the analysis.
Clean the glass liner frequently and replace the glass wool
when ever required.
Clean the FID detector frequently with solvents like
Methylene chloride.
Ensure that the pressure of gas cylinder is sufficient for
analysis.
After
installation of the column check for any leakage using (IPA: water) 50:50
•
Dissolution
Ensure that the apparatus is in calibrated state before use.
Before start of analysis, ensure cleanliness of dissolution
bath. Check the physical calibration like RPM, distance of shaft from center of
jar, integrity of basket mesh etc.
Check the temperature of dissolution medium before and after
dissolution analysis by using thermometer.
Use calibrated accessories for checking physical parameters.
Weigh the tablets / capsules before adding in
the dissolution medium.
Ensure that the dissolution medium is degassed before use
& check previous product cleanliness.
After
completion of the specified time interval of the dissolution test physically
check for the appearance of the content in the dissolution bowl whether there
is any lump formation / non-disintegration of the tablet or capsule / or any
other irregular observation.
•
Atomic Adsorption Spectroscopy
Ensure that the system is in calibrated state before use.
Before start of analysis ensure that, the pressure of gases
is intact and there is no leak of gases.
Ensure all safety features are on (Blower, safety goggles).
Ensure that the correct lamp is used for analysis.
Monitor the lamp energy regularly.
Check the liquid level of water container.
Whenever possible and required use micro pipettes for
dilutions.
Ensure that the matrix of sample is matching with the blank.
After
analysis wash the burner with sufficient water / in dilute hydrochloric acid.
•
Titration
Before start of analysis ensure that the correct volumetric
solution with correct morality are used.
Before start of analysis, molarity should be checked by
second person.
Ensure that the molarity of solution is valid while
performing the titration
Use correct indicator and ensure its validity.
Cautiously determine the end point when it is visual
determination of end point.
For Potentiometric titration ensure that the reference
solution is available in the electrode.
Properly condition the electrode and regenerate the electrode
if required.
After
completion of analysis store electrode in its respective solution.
• pH
Meter
Ensure all the connections of the instrument are proper
before use.
Unless otherwise specified carry out all the measurements of
pH at temperature 25oC ± 2oC.
Make the relevant entries in the instrument log book after
using the instrument.
Wash the electrode and temperature probe with water and wipe
neatly with tissue paper.
Calibrate the pH meter before each use selecting two buffers
such that the expected pH of the material falls in between the buffer
selected and whose difference in pH does not exceed 4 units.
After calibration is over, wash the electrode and temperature
probe with water 3 to 4 time and immerse the electrode and temperature probe in
the solution to be examined.
After use wash the electrode and temperature probe with water
and wipe neatly with tissue paper. Then immerse the electrode and temperature
probe in buffer solution having pH 7 saturated with KCl (Prepare this solution
after every seven days or early if required).
Calibrate the pH meter daily with pH buffers 1.68, 4.01,
6.86, 9.18 and 12.45 and record the observations in the calibration record
register.
Once in a month perform the pH meter slope determination.
Reactivation of electrode to be done whenever necessary.
For reactivation of electrode remove all previous potassium
chloride solution (saturated) from the electrode.
Inject the potassium chloride solution (saturated) up to the
hole of electrode.
Dip the
electrode in 0.1M HCl for a period of
minimum 24 hours.
•
Conductivity meter
Ensure that the instrument is in calibrated condition before
use.
Ensure all the connections of the instrument are proper
before use.
Ensure the correct electrode is connected to instrument and
is properly cleaned and stored.
Ensure that the temperature sensor is connected to the
instrument.
After use wash the electrode and temperature probe with water
and wipe neatly with tissue paper. Then immerse the electrode and
temperature probe sufficiently deep in the beaker containing sample solution.
Make the relevant entries in the instrument log book after
using the instrument.
Calibrate the instrument daily.
If the electrode constant “K” is out of limit, Calibration
shall be repeated by preparing fresh standard solution.
Even after recalibration, If the electrode constant “K” lies
out of limit, probe should be reactivated by replatinizing (done by external
party).
After rechecking if an acceptance criterion is not met, then
replace the electrode.
