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.
筛选结果
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- 产品代码 MM0487.09AME-00.20
- CAS登记号 62-75-9
- 品牌: Mikromol
- 产品类型: Impurity
- 产品形式: Single Solution
- API家族: Nizatidine, Cilostazol, Candesartan Cilex...
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- 产品代码 TRC-N525467
- CAS登记号 1346603-41-5
- 品牌: TRC
- 产品类型: Impurity, Stable Isotope Labelled
- 产品形式: Neat
- Purity: >95% (HPLC)
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- 产品代码 MM0011.12-0025
- CAS登记号 63779-86-2
- 品牌: Mikromol
- 产品类型: Impurity
- 产品形式: Neat
- API家族: Hydrochlorothiazide
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- 产品代码 TRC-N529002
- CAS登记号 1184996-41-5
- 品牌: TRC
- 产品类型: Impurity, Stable Isotope Labelled
- 产品形式: Neat
- Purity: >95% (HPLC)
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- 产品代码 MM0487.10AME-00.10
- CAS登记号 55-18-5
- 品牌: Mikromol
- 产品类型: Impurity
- 产品形式: Single Solution
- API家族: Valsartan, Irbesartan, Losartan Potassium
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- 产品代码 TRC-KIT9105-1X1ML
- CAS登记号 1219794-54-3
- 品牌: TRC
- 产品类型: Impurity, Stable Isotope Labelled
- 产品形式: Single Solution
- 分析方法: NMR, MS
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- 产品代码 TRC-N171730
- CAS登记号 150494-06-7
- 品牌: TRC
- 产品类型: Impurity
- 产品形式: Neat
- Purity: >95% (HPLC)
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- 产品代码 TRC-KIT8442-1X1ML
- CAS登记号 1184996-41-5
- 品牌: TRC
- 产品类型: Stable Isotope Labelled, Impurity
- 产品形式: Single Solution
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- 产品代码 TRC-A263601
- 品牌: TRC
- 产品类型: Impurity, Stable Isotope Labelled
- 产品形式: Neat
- Purity: >95% (HPLC)
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- 产品代码 TRC-N535002
- CAS登记号 66148-19-4
- 品牌: TRC
- 产品类型: Impurity, Stable Isotope Labelled
- 产品形式: Neat
- Purity: >95% (HPLC)
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- 产品代码 TRC-N524246
- CAS登记号 1133-64-8
- 品牌: TRC
- 产品类型: Impurity, Metabolite
- 产品形式: Neat
- Purity: >95% (HPLC)
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- 产品代码 TRC-M325803
- CAS登记号 756524-88-6
- 品牌: TRC
- 产品类型: Impurity, Stable Isotope Labelled
- 产品形式: Neat
- Purity: >95% (GC)
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- 产品代码 TRC-KIT8440-1X1ML
- CAS登记号 61445-55-4
- 品牌: TRC
- 产品类型: Impurity
- 产品形式: Single Solution
- 产品代码 TRC-N137620
- 品牌: TRC
- 产品类型: Impurity
- 产品形式: Neat
- Purity: >95% (HPLC)
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- 产品代码 TRC-N525225
- CAS登记号 53609-64-6
- 品牌: TRC
- 产品类型: Impurity
- 产品形式: Neat
- Purity: >95% (HPLC)
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- 产品代码 TRC-KIT8365-1X1ML
- CAS登记号 16339-04-1
- 品牌: TRC
- 产品类型: Impurity
- 产品形式: Single Solution
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- 产品代码 TRC-N396192
- 品牌: TRC
- 产品类型: Impurity, Stable Isotope Labelled
- 产品形式: Neat
- Purity: >95% (HPLC)
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