Analytik-jena의 'Application Note•multi N/C pharma'을 이용한 응용자료는 어날리틱예나코리아(유)에서 제공하였으며 주요 내용은 다음과 같다.
Introduction
The USP <643> represents the general method for TOC testing in pharmaceutical applications and provides guidance on how to qualify the analytical technique for use as well as guidance on how to interpret instrument results for use as a limit test.
The revised TOC monograph <643> was implemented with the release of USP 37.
It now describes two different TOC testing approaches addressing different pure water qualities, which are “Bulk Water”(e.g., Purified Water [PF], Water for Injection [WFI], Water for Hemodialysis, and condensate of Pure Steam) and “Sterile Water” (e.g., Sterile Water for Injection [SWFI], Sterile Purified Water [SPW], Sterile Water for Irrigation, and Sterile Water for Inhalation).
For bulk water quality, the testing procedure and limit values were retained as established:
For the sterile water quality, the testing procedure was slightly modified and new limit
This application note demonstrates that the multi NC pharma allows straightforward and reliable TOC testing for sterile water according to the newly established SST.
Material & Methods
Sample Preparation and Measurement
Samples were taken from tap water and water from a filtration plant, where different filters were applied to clean up raw water. The samples had been stored in the refrigerator at 4°C. System suitability test solutions of 8mg/L sucrose and p-benzoquinone, respectively, were prepared from 100mg/L stock solutions by dilution with ultrapure water from the ultrapure water plant in the lab and subsequently run with the SST sequence integrated in the software before the samples were measured.
After several rinse steps the samples were filled into 40mL sampler vials, sealed with aluminum foil, and placed into the AS vario sample rack. Using the autosampler, the samples were acidified with 1 M H2SO4(multi N/C pharma UV) and 2 M HCl(multi N/C 3100 pharma), respectively, and subsequently purged with the carrier gas according to the method settings for complete TIC removal prior to NPOC measurement.
During the oxidation process in the high-power, long-life UV reactor or in the Pt catalyst filled combustion tube, respectively all carbon compounds are quantitatively converted to CO₂. The wide-range Focus Radiation NDIR Detector was used for quantitative determination of CO₂ content in the measurement gas.
Calibration
The multi N/C pharma analyzers were calibrated for NPOC in the range from 0.2 to 20mg/L with standard solutions prepared from a 1000 mg/L sucrose stock solution. A multipoint calibration type was used. The calibration curve and its characteristics are shown in Figure 1.
Instrumentation
The following method settings were used to determine the TOC content:
Results & discussion
After system calibration, 2tap water and 2filtrated water samples were measured as described above and subsequent SST sequence run.
Results are displayed in the table below.
Conclusion
The revision of the TOC-related USP monograph has broadened the pharma application range for TOC analyzers. Additionally, a new monograph USP <661.1> was implemented for testing of extractables from packing materials. According to this method, purified water extractions from polymer packing materials are prepared under the described conditions and tested for TOC within 4 hours after preparation according to USP<643>.
The TOC method to be used needs to provide a linear dynamic range from 0.2 to 20mg/L TOC with a detection limit of max. 0.2mg/L.
This application note clearly demonstrates that the multi N/C pharma analyzers with their high-oxidation power and sophisticated design provide the required performance characteristics for the new challenges in pharmaceutical TOC testing beyond the 500 ppb limit.
Analytik-jena의 'Application Note•multi N/C pharma'에 대한 궁금한 내용은 본 원고자료를 제공한 어날리틱예나코리아(유)를 통하여 확인할 수 있다.
Reference(참고문헌): Analytik jena AG Application Note.
: Bletzinger, B.; Êtes-vous prêt à relever les exigences du TOC des nouvelles méthodes USP? La Gazette, September 2016.
: Bletzinger, B.; Are you fit for the TOC challenges according to new USP regulations? GIT Labor-Fachzeitschrift, October 2016.
Model Name(모델명): multi N/C pharma
The Person in Charge(담당자): BumJun Oh
Maker(제조사): Analytik-jena
Country of Origin(원산지): Germany
e-mail: bum-jun.oh@analytik-jena.com
Data Services(자료제공): Analytik-jena Korea
<이 기사는 사이언스21 매거진 2020년 10월호에 게재 되었습니다.>
Analytik-jena의 'Application Note•multi N/C pharma'을 이용한 응용자료는 어날리틱예나코리아(유)에서 제공하였으며 주요 내용은 다음과 같다.IntroductionThe USP <643> represents the general method for TOC testing in pharmaceutical applications and provides guidance on how to qualify the analytical technique for use as well as guidance on how to interpret instrument results for use as a limit test.The revised TOC monograph <643> was implemented with the release of USP 37.It now describes two different TOC testing approaches addressing different pure water qualities, which are “Bulk Water”(e.g., Purified Water [PF], Water for Injection [WFI], Water for Hemodialysis, and condensate of Pure Steam) and “Sterile Water” (e.g., Sterile Water for Injection [SWFI], Sterile Purified Water [SPW], Sterile Water for Irrigation, and Sterile Water for Inhalation).For bulk water quality, the testing procedure and limit values were retained as established:
For the sterile water quality, the testing procedure was slightly modified and new limit
This application note demonstrates that the multi NC pharma allows straightforward and reliable TOC testing for sterile water according to the newly established SST.Material & MethodsSample Preparation and MeasurementSamples were taken from tap water and water from a filtration plant, where different filters were applied to clean up raw water. The samples had been stored in the refrigerator at 4°C. System suitability test solutions of 8mg/L sucrose and p-benzoquinone, respectively, were prepared from 100mg/L stock solutions by dilution with ultrapure water from the ultrapure water plant in the lab and subsequently run with the SST sequence integrated in the software before the samples were measured.After several rinse steps the samples were filled into 40mL sampler vials, sealed with aluminum foil, and placed into the AS vario sample rack. Using the autosampler, the samples were acidified with 1 M H2SO4(multi N/C pharma UV) and 2 M HCl(multi N/C 3100 pharma), respectively, and subsequently purged with the carrier gas according to the method settings for complete TIC removal prior to NPOC measurement.During the oxidation process in the high-power, long-life UV reactor or in the Pt catalyst filled combustion tube, respectively all carbon compounds are quantitatively converted to CO₂. The wide-range Focus Radiation NDIR Detector was used for quantitative determination of CO₂ content in the measurement gas.CalibrationThe multi N/C pharma analyzers were calibrated for NPOC in the range from 0.2 to 20mg/L with standard solutions prepared from a 1000 mg/L sucrose stock solution. A multipoint calibration type was used. The calibration curve and its characteristics are shown in Figure 1.
InstrumentationThe following method settings were used to determine the TOC content:
Results & discussionAfter system calibration, 2tap water and 2filtrated water samples were measured as described above and subsequent SST sequence run.Results are displayed in the table below.
ConclusionThe revision of the TOC-related USP monograph has broadened the pharma application range for TOC analyzers. Additionally, a new monograph USP <661.1> was implemented for testing of extractables from packing materials. According to this method, purified water extractions from polymer packing materials are prepared under the described conditions and tested for TOC within 4 hours after preparation according to USP<643>.The TOC method to be used needs to provide a linear dynamic range from 0.2 to 20mg/L TOC with a detection limit of max. 0.2mg/L.This application note clearly demonstrates that the multi N/C pharma analyzers with their high-oxidation power and sophisticated design provide the required performance characteristics for the new challenges in pharmaceutical TOC testing beyond the 500 ppb limit.Analytik-jena의 'Application Note•multi N/C pharma'에 대한 궁금한 내용은 본 원고자료를 제공한 어날리틱예나코리아(유)를 통하여 확인할 수 있다.Reference(참고문헌): Analytik jena AG Application Note.: Bletzinger, B.; Êtes-vous prêt à relever les exigences du TOC des nouvelles méthodes USP? La Gazette, September 2016.: Bletzinger, B.; Are you fit for the TOC challenges according to new USP regulations? GIT Labor-Fachzeitschrift, October 2016.Model Name(모델명): multi N/C pharmaThe Person in Charge(담당자): BumJun OhMaker(제조사): Analytik-jenaCountry of Origin(원산지): Germanye-mail: bum-jun.oh@analytik-jena.comData Services(자료제공): Analytik-jena Korea<이 기사는 사이언스21 매거진 2020년 10월호에 게재 되었습니다.>