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Organic parameters
Organic sum parameters: TOC (Total Organic Carbon) and THC (Total Hydrocarbon)
The TOC value is a sum parameter for water-soluble organic substances. For its determination, organic compounds are oxidized to carbon dioxide (CO2) and then measured using GC-WLD (Gas Chromatography with a Wide Range Detector).
Complementarily, we determine the content of Total Hydrocarbons (THC) using GC-FID (Gas Chromatography with Flame Ionization Detection).
Please find additional relevant documents in our download area.
Ph. Eur. 2.2.28 – Gas chromatography [accredited method: PL-19422-01]
Inorganic parameters
Residue determination: EO (Ethylene oxide) and ECH (Ethylene chlorohydrin)
For many years, we have successfully conducted the determination of sterilization residues from ethylene oxide sterilization for renowned European and international manufacturers.
Please find additional relevant documents in our download area.
DIN EN ISO 10993-7 [accredited method: PL-19422-01]
Chromatography
Residue determination: General chemical impurities
We sample surfaces for chemical impurities after desorption using GC (Gas Chromatography) and HPLC (High Performance Liquid Chromatography).
Please find additional relevant documents in our download area.
Ph. Eur. 2.2.28 – Gas chromatography [accredited method: PL-19422-01]
Ph. Eur. 2.2.29 – Liquid chromatography [accredited method: PL-19422-01]
Particle analysis
Residue determination: Particulate contaminants
To determine particulate contaminants on surfaces, we utilize the following techniques:
- FT-IR spectroscopy (for contaminants of organic origin)
Ph. Eur. 2.2.24 – Infrared spectroscopy [accredited method: PL-19422-01]
- Scanning Electron Microscopy with Energy Dispersive X-ray Spectroscopy (SEM-EDX) (for contaminants of inorganic origin)
DIN ISO 22309 [accredited method: PL-19422-01]
- Optical Microscopy JOMESA (for general contaminants)
Please find additional relevant documents in our download area.
Residual dirt analysis
VOC, SVOC: Determination of volatile organic compounds
We investigate articles for the release of organic volatile and semi-volatile compounds using GC (Gas Chromatography) and HPLC (High Performance Liquid Chromatography).
Please find additional relevant documents in our download area.
Ph. Eur. 2.2.28 – Gas chromatography [accredited method: PL-19422-01]
Ph. Eur. 2.2.29 – Liquid chromatography [accredited method: PL-19422-01]
Residue analysis
NVOC: Determination of non-volatile organic components
We investigate articles for the release of non-volatile organic compounds using HPLC-MS and UPLC-MS.
Please find additional relevant documents in our download area.
In the current accreditation process:
Ph. Eur. 2.2.43 – Mass spectrometry
Inorganic parameters
Inorganic parameters: Metallic contaminants
Metallic contaminants can occur in various forms. To determine them, we use the following techniques:
- Ion chromatography (anions and cations)
Ph. Eur. 2.2.29 – Liquid chromatography [accredited method: PL-19422-01]
- ICP-MS (elements)
Ph. Eur. 2.2.58 – Mass spectrometry with inductively coupled plasma [accredited method: PL-19422-01]
- Scanning Electron Microscopy with Energy Dispersive X-ray Spectroscopy (SEM-EDX)
DIN ISO 22309 [accredited method: PL-19422-01]
Please find additional relevant documents in our download area.
Active Ingredient Analysis
Active Ingredient Analysis
SAS Hagmann supports clients in conducting Environmental Risk Assessments (ERA) as required for the approval processes of pharmaceuticals according to the European Medicines Agency (EMA) standards. A registration dossier for the market authorization of human medicinal products (HMP) must mandatorily include an ERA, which evaluates the intended use in the dosage form, the physicochemical and ecotoxicological properties, and the environmental behavior of the active ingredient.
The necessary risk assessment is divided into phases, during which chemical and biological analyses are conducted according to widely recognized OECD protocols.
In addition to sampling the actual pharmaceutical active ingredients (API), SAS Hagmann assists clients in implementing risk management measures such as ICH Q3, which aim to evaluate the entire pharmaceutical product, including not only the active ingredients but also excipients, precursor compounds, and other process-involved reagents.
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Weitere Ergebnisse
Organic parameters
Organic sum parameters: TOC (Total Organic Carbon) and THC (Total Hydrocarbon)
The TOC value is a sum parameter for water-soluble organic substances. For its determination, organic compounds are oxidized to carbon dioxide (CO2) and then measured using GC-WLD (Gas Chromatography with a Wide Range Detector).
Complementarily, we determine the content of Total Hydrocarbons (THC) using GC-FID (Gas Chromatography with Flame Ionization Detection).
Please find additional relevant documents in our download area.
Ph. Eur. 2.2.28 – Gas chromatography [accredited method: PL-19422-01]
Inorganic parameters
Residue determination: EO (Ethylene oxide) and ECH (Ethylene chlorohydrin)
For many years, we have successfully conducted the determination of sterilization residues from ethylene oxide sterilization for renowned European and international manufacturers.
Please find additional relevant documents in our download area.
DIN EN ISO 10993-7 [accredited method: PL-19422-01]
Chromatography
Residue determination: General chemical impurities
We sample surfaces for chemical impurities after desorption using GC (Gas Chromatography) and HPLC (High Performance Liquid Chromatography).
Please find additional relevant documents in our download area.
Ph. Eur. 2.2.28 – Gas chromatography [accredited method: PL-19422-01]
Ph. Eur. 2.2.29 – Liquid chromatography [accredited method: PL-19422-01]
Particle analysis
Residue determination: Particulate contaminants
To determine particulate contaminants on surfaces, we utilize the following techniques:
- FT-IR spectroscopy (for contaminants of organic origin)
Ph. Eur. 2.2.24 – Infrared spectroscopy [accredited method: PL-19422-01]
- Scanning Electron Microscopy with Energy Dispersive X-ray Spectroscopy (SEM-EDX) (for contaminants of inorganic origin)
DIN ISO 22309 [accredited method: PL-19422-01]
- Optical Microscopy JOMESA (for general contaminants)
Please find additional relevant documents in our download area.
Residual dirt analysis
VOC, SVOC: Determination of volatile organic compounds
We investigate articles for the release of organic volatile and semi-volatile compounds using GC (Gas Chromatography) and HPLC (High Performance Liquid Chromatography).
Please find additional relevant documents in our download area.
Ph. Eur. 2.2.28 – Gas chromatography [accredited method: PL-19422-01]
Ph. Eur. 2.2.29 – Liquid chromatography [accredited method: PL-19422-01]
Residue analysis
NVOC: Determination of non-volatile organic components
We investigate articles for the release of non-volatile organic compounds using HPLC-MS and UPLC-MS.
Please find additional relevant documents in our download area.
In the current accreditation process:
Ph. Eur. 2.2.43 – Mass spectrometry
Inorganic parameters
Inorganic parameters: Metallic contaminants
Metallic contaminants can occur in various forms. To determine them, we use the following techniques:
- Ion chromatography (anions and cations)
Ph. Eur. 2.2.29 – Liquid chromatography [accredited method: PL-19422-01]
- ICP-MS (elements)
Ph. Eur. 2.2.58 – Mass spectrometry with inductively coupled plasma [accredited method: PL-19422-01]
- Scanning Electron Microscopy with Energy Dispersive X-ray Spectroscopy (SEM-EDX)
DIN ISO 22309 [accredited method: PL-19422-01]
Please find additional relevant documents in our download area.
Active Ingredient Analysis
Active Ingredient Analysis
SAS Hagmann supports clients in conducting Environmental Risk Assessments (ERA) as required for the approval processes of pharmaceuticals according to the European Medicines Agency (EMA) standards. A registration dossier for the market authorization of human medicinal products (HMP) must mandatorily include an ERA, which evaluates the intended use in the dosage form, the physicochemical and ecotoxicological properties, and the environmental behavior of the active ingredient.
The necessary risk assessment is divided into phases, during which chemical and biological analyses are conducted according to widely recognized OECD protocols.
In addition to sampling the actual pharmaceutical active ingredients (API), SAS Hagmann assists clients in implementing risk management measures such as ICH Q3, which aim to evaluate the entire pharmaceutical product, including not only the active ingredients but also excipients, precursor compounds, and other process-involved reagents.
