---
title: IL-36: Quantitative analysis of dissolved organic and/or inorganic carbon as well as nitrogen
description: The cleanliness of medical devices (MDs) is a critical factor and is dealt with in ISO 19227, for example.
---

[RMS Foundation l News ](https://www.rms-foundation.ch/en/news)

# [IL-36: Quantitative analysis of dissolved organic and/or inorganic carbon as well as nitrogen](https://www.rms-foundation.ch/en/news/il-36-quantitative-bestimmung-des-geloesten-kohlenstoffs-und-stickstoffs)

 Written by [RMS Foundation](https://www.rms-foundation.ch/en/news/author/rms) | 07.11.2024

#### Principle of the method:

Possible Impurities containing carbon and nitrogen are extracted from the product and the corresponding elements are then reliably detected down to the sub-µg range (depending on the size of the MD). The molecules of the dissolved impurities are catalytically oxidized in a combustion tube to form CO2 or NO2 and the resulting gases are quantified spectroscopically.

#### Typical application:

Any impurities on the test device are first extracted by a solvent and then the solution is analyzed for organic carbon (C) and/or nitrogen (N). The extraction is performed «exhaustively», i.e. it is repeated until the measured impurity concentration in the extraction solution falls below 10% of the first extraction. The quantified amounts of each extraction are summed up to give the total amount of organic impurity. ISO 19227 specifies a limit value of max. 0.5 mgC/implant. 

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*Figures: Possible Task: MP is soiled, cleaned, and any organic residues in the extraction solution are reliably quantified using TOC/TIC/TN.*

#### Our offerings for medical device cleanliness testing

- Shimadzu» TOC-L Analyzer
- Determination of dissolved organic carbon (TOC)
- Determination of the dissolved inorganic carbon (TIC)
- Determination of the dissolved nitrogen (TN: total nitrogen, e.g. from proteins)

#### Other services

- Quantification of residual protein (BCA test)
- Quantification of trace elements by ICP-MS
- Cleanliness of surfaces by SEM/EDX and XPS
- Particle analysis by laser diffraction (LD) and light obscuration (LO)

[View full post](https://www.rms-foundation.ch/en/news/il-36-quantitative-bestimmung-des-geloesten-kohlenstoffs-und-stickstoffs)

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