Nitrosamine Reference Materials
Nitrosamines are carcinogenic impurities: generally categorised as small molecule nitrosamines, which can be found in any drug product, or Nitrosamine Drug Substance Related Impurities (NDSRIs) related to specific APIs.
Discovery of N-Nitrosamines in a drug product can seriously undermine patient trust in a medication, as well as causing product recalls and global drug shortages.
Current nitrosamine regulation includes FDA and EMA guidance on setting acceptable limits for small molecule nitrosamines and NDSRIs through a Carcinogenic Potency Categorization Approach (CPCA).
Our wide range of highly pure small molecule nitrosamine and NDSRI reference materials allow you to ensure that your pharmaceutical testing, research and analysis all comply with FDA and EMA specifications.
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- Product Code: TRC-C183875
- CAS Number: 154-93-8
- Brand: TRC
- Product type: API
- Product Format: Neat
- Purity: >95% (HPLC)
- Product Code: TRC-KIT8940-1X1ML
- CAS Number: 7068-83-9
- Brand: TRC
- Product type: API
- Product Format: Single Solution
- Product Code: MM0487.09AME-00.20
- CAS Number: 62-75-9
- Brand: Mikromol
- Product type: Impurity
- Product Format: Single Solution
- API family: Nizatidine, Cilostazol, Candesartan Cilex...
- Product Code: TRC-N525467
- CAS Number: 1346603-41-5
- Brand: TRC
- Product type: Impurity, Stable Isotope Labelled
- Product Format: Neat
- Purity: >95% (HPLC)
- Product Code: MM0011.12-0025
- CAS Number: 63779-86-2
- Brand: Mikromol
- Product type: Impurity
- Product Format: Neat
- API family: Hydrochlorothiazide
- Product Code: TRC-N529002
- CAS Number: 1184996-41-5
- Brand: TRC
- Product type: Impurity, Stable Isotope Labelled
- Product Format: Neat
- Purity: >95% (HPLC)
- Product Code: MM0487.10AME-00.10
- CAS Number: 55-18-5
- Brand: Mikromol
- Product type: Impurity
- Product Format: Single Solution
- API family: Valsartan, Irbesartan, Losartan Potassium
- Product Code: TRC-KIT9105-1X1ML
- CAS Number: 1219794-54-3
- Brand: TRC
- Product type: Impurity, Stable Isotope Labelled
- Product Format: Single Solution
- Analytical Method: NMR, MS
- Product Code: TRC-N171730
- CAS Number: 150494-06-7
- Brand: TRC
- Product type: Impurity
- Product Format: Neat
- Purity: >95% (HPLC)
- Product Code: TRC-KIT8442-1X1ML
- CAS Number: 1184996-41-5
- Brand: TRC
- Product type: Stable Isotope Labelled, Impurity
- Product Format: Single Solution
- Product Code: TRC-A263601
- Brand: TRC
- Product type: Impurity, Stable Isotope Labelled
- Product Format: Neat
- Purity: >95% (HPLC)
- Product Code: TRC-N535002
- CAS Number: 66148-19-4
- Brand: TRC
- Product type: Impurity, Stable Isotope Labelled
- Product Format: Neat
- Purity: >95% (HPLC)
- Product Code: TRC-N524246
- CAS Number: 1133-64-8
- Brand: TRC
- Product type: Impurity, Metabolite
- Product Format: Neat
- Purity: >95% (HPLC)
- Product Code: TRC-M325803
- CAS Number: 756524-88-6
- Brand: TRC
- Product type: Impurity, Stable Isotope Labelled
- Product Format: Neat
- Purity: >95% (GC)
- Product Code: TRC-KIT8440-1X1ML
- CAS Number: 61445-55-4
- Brand: TRC
- Product type: Impurity
- Product Format: Single Solution
- Product Code: TRC-N137620
- Brand: TRC
- Product type: Impurity
- Product Format: Neat
- Purity: >95% (HPLC)
- Product Code: TRC-N525225
- CAS Number: 53609-64-6
- Brand: TRC
- Product type: Impurity
- Product Format: Neat
- Purity: >95% (HPLC)
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