Interested to Buy Any Domain ? << Click Here >> for more details...
acceptance criteria for ph meter, hplc
detector,pump,injector,oven when we calibrate.
- 3 Answers
- 24866 Views
- I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / guest
Acceptance Criteria
---------------------
pH Meter:
-----------
Perform 2 point or 3 point calibration as per the
use/requirement.
The slope should be 95% to 105%
Where as pH measured value for known pH buffer should be
4.01 ± 0.05
7.00 ± 0.05
9.21 ± 0.05
10.00 ± 0.05
11.00 ± 0.05
HPLC Detector:
--------------
Prepare differenct concentration of caffeine solution say
10 ppm, 25 ppm, 50 ppm, 75 ppm, 100 ppm, and 125 ppm.
Inject single injection of each solution and calculate the
correlation coefficient = sholud be 0.999
HPLC Pump:
----------
a) Flow rate accuracy
b) GPV
a) Flow rate accuracy:
Calculate flow rate accuracy using water at difference flow
rate at 0.5 mL/min , 1.0 mL/min, and 3.0 mL/min at duration
of 5 minutes and calculate the volume collected with in 5
minutes duration using stop watch collected in pre-weigh
calss A volumetric flask.Apply density of water at
specified temperature.
Acceptance Criteria: For all the flow rate should be ± 5%
b) Gradient Proportianating Value (GPV)
GPV test will be perform using 5.6 mg of Propyl paraben ----
-} 1000 mL of methanol for channel A and B if we are
calibrating the Quadranaery pump and C and D channels in
methanol run the gradient composition at the specified time
to obtain the response when compared with higest response
of methanol vs propyl paraben solution should be 10 ± 0.5
i.e 9.5 - 10.5.
We can even calibrate using 0.5% Acetone in water by
evaluating the response obtained throughout the run time.
Injector:
---------
a) Injector Linearity
b) Injector precision
c) Volume accuracy
a) Injector Linearity
Inject singe injection of 25ppm caffeine solution of
injection volume 5µ, 10µ, 20µ, 50µ and 100µ. if the
injector loop is 100 µl loop where as if the injector loop
is 200 µl then go upto 200 µl for better accuracy.
Acceptance criteria: Correlation coefficient: 0.999
b) Injector Precision:
Inject 5 times of 25 ppm caffeine solution and calculate
the RSD for area.
Accetance criteria: < 1.0%
c) Volume Accuracy:
Check the injector volume accuracy by intecting the 5µl
volume for 10 times in a pre-weigh vial containing water.
Check the injector volume accuracy by intecting the 10µl
volume for 10 times in a pre-weigh vial containing water.
Acceptance criteria: 4.95 - 5.05 µl
19.5 - 20.5 µl
Column Oven:
------------
Calibrate the column oven with calibrated
thermometer/digital at 30° C and 70°C
Acceptance Criteria: 30 ± 2 °C
70 ± 2 °C
| Is This Answer Correct ? | 19 Yes | 1 No |
Answer / saptale maruti
Flow rate ± 0.2% of set value
Flow rate consistancy RSD NMT1.0%
Compositional Accuaracy : Difference in Absorbance is 0.01AU
Difference in time NMT 20SEc
Delay Volume NMT 4.5 (For 4 ml Delay Volume System)
Injection Volume Accuracy is : Average volume for 18
injection is 19.6 to 20.4µl
Linearity 0.999
Wavelenght Accuracy Maxima 273± 2 nm
Minima 205 and 245± 2 nm
Oven Temperature 2 degree from set temp.
For Ph ± 0.02
| Is This Answer Correct ? | 7 Yes | 2 No |
Answer / basha
For pH + OR - 0.05
HPLC-DETECTOR + OR - 1nm
Acceptance Criteria: For all the flow rate should be ± 0.02
Acceptance criteria: Correlation coefficient: 0.98
Accetance criteria for volume:1 %
Acceptance Criteria: ± 1 °C
| Is This Answer Correct ? | 6 Yes | 7 No |
What is aggregate and fragments in SEC?
What is difference between NDA & ANDA ?
on what basis SOP's can be changed? IF mobile phase ratio is 70:30 to how much % can we change the ratio in HPLC process
Why do we need GC instead of HPLC? or Why do we need HPLC instead of GC?
why disodium tartarate used in karl-fischer instrument ?.
What is the major difference b/w Drift and Noise
4 Answers Aurobindo, Dr Reddys, Reddy Labs,
How do we fix the sample concentaryion in hplc method development. What is the basis?
pharma industries oriented
0 Answers Apex, Micro Labs, Zydus Cadila,
why has inject 5 injection in assay
what is mean by profiling of dissolution
How to fix the sample concentration in related substances development.
3 Answers Novartis, Watson Pharmaceuticals,
What is the limit of minimum area in in hplc RS anlysis
Organic Chemistry 
