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SOP for Calibration of Shimadzu Total Organic Carbon (TOC) Analyzer

Objective
To check the performance of Shimadzu Total Organic Carbon Analyzer.

Scope
This procedure is applicable to calibrate Shimadzu Total Organic Carbon Analyzer.

Responsibility
Doing: Technical Assistant
Checking: Executive /Manager

Accountability
Head of the Department

Procedure
  • Clean the instrument with a dry cotton cloth.
  • Operate the instrument as per S.O.P.
Performance check of TOC
  • TC : Dissolve 0.5950 gm. of sucrose in 500 ml of water to get 500 ppm of carbon and further dilute with water to get final concentration 250 ppb, 500 ppb and 750 ppb of carbon.
  • IC : Dissolve 0.875 gm NaHCO3 and 1.1025 gm of Na2CO3 in 500 ml of water to get 500 ppm IC standard and further dilute with waters to get final concentration 250 ppb, 500ppb and 750 ppb of carbon
  • NPOC : Dissolve 0.5950 gm of sucrose in 500 ml of water to get 500 ppm of carbon and further dilute with water to get final concentration 250 ppb, 500 ppb and 750 ppb of carbon. Add 1ml 2N HCl in 250, 500, 550 ppb solution.
  • Analyse the samples of step above and check the linearity, report in Annexure-I.

For System Suitability
  • Preparation of 500 ppb benzoquinone solution: Dissolve 0.375 gm. benzoquinone in 500 ml of water to get 500 ppm of carbon and further dilute and analyze with water to get final concentration 500 ppb of carbon and analyze solution as a sample.
  • Add 1ml of 2N HCl in 500 ppb benzoquinione solution.
  • Calculate the system suitability by the following calculation.
Where 
Rss = Mean area count of 1,4 benzoquinone solution
Rs = Mean area count of sucrose (500 ppb of carbon)
Rw = Mean area count of pure water


Area of Limit
  • Pure water should be more than 10,000 ( 0.25μcg carbon)
  • System suitability : Between 85% to 115% of theoretical response.
  • Report the results.

Performance check of SSM

Total organic carbon
  • Take 2.5 mg. of Glucose for 1000 μcg std. carbon
  • Take 5.0 mg. of Glucose for 2000 μcg std. carbon
  • Take 7.5 mg. of Glucose for 3000 μcg std. carbon
  • Take 10.0 mg. of Glucose for 4000 μcg std. carbon
  • Inorganic carbon
  1. Take 8.85 mg. of Na2CO3 for 1000 μcg std. carbon
  2. Take 17.7 mg. of Na2CO3 for 2000 μcg std. carbon
  3. Take 26.55 mg. of Na2CO3 for3000 μcg std. carbon
  • Generate 4 point calibration curve for SSMTC and SSMIC with the point of 1000, 2000,3000, 4000 μcg standards.
  • In calibration condition “Set the
  1. 1st std. concentration as 40 and AMNT 2.5mg
  2. 2nd std. concentration as 40 and AMNT 5.0mg
  3. 3rd std. concentration as 40 and AMNT 7.5mg
  4. 4th std. concentration as 40 and AMNT 10 mg
  • Set the range as per requirement
  • Press “O.K” and then press the start button.
  • After completion all four std. shift to original function in ‘cal curve’ screen before using.
  • Similarly create a calibration curve for various std.

A. Frequency for Total organic carbon
  1. For TC and IC = Once in a six month
  2. For NPOC = Once in a month
  3. For system suitability: Once in three month

B. Frequency for SSM
TC and IC = Once in a six month

ABBREVIATIONS
ppb= Parts per billion
ppm = Parts per million
μcg = Microgram
gm =gram
Na2CO3 = Sodium carbonate
TC= Total Carbon
NPOC = Non Purgeable Organic Carbon
IC= Inorganic carbon
SSMTC=Solid Sample Module Total Carbon
SSMIC=Solid Sample Module Inorganic Carbon
SSM= Solid Sample Module
NaHCO3 = Sodium bi carbonate
API= Active pharmaceutical ingredient

ANNEXURE

REVISION HISTORY
Nil

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