🚨 Concerned about Nitrosamine Contamination?
You're not alone. Regulatory bodies across the globe are cracking down on N-Nitroso impurities, demanding trace-level detection and impurity profiling across APIs and formulations. Failure to comply can lead to costly recalls and regulatory holds.
At KarpsChem Laboratories Pvt. Ltd., we’ve got your back with high-purity N-Nitroso impurities—synthesized in-house, verified by robust analytical data, and available in ready stock.
🔬 Why N-Nitroso Impurities Matter:
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⚠️ Classified as probable carcinogens (ICH M7 Class 1)
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📉 Acceptable limits are extremely low (as low as 18 ng/day in some APIs)
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📑 Essential for regulatory submissions, risk assessments, and stability studies
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🧪 Detected in APIs like Valsartan, Ranitidine, Metformin, Fluoxetine, and more
✅ In-Stock N-Nitroso Impurities at KarpsChem:
| Impurity Name | Description |
|---|---|
| N-Nitroso Fluoxetine | Impurity in SSRIs like Fluoxetine |
| N-Nitroso Valsartan Desvaleryl Impurity | Detected in ARB class APIs |
| N-Nitroso Desvaleryl Methyl Ester Impurity | Degradation impurity in sartans |
| N-Nitroso Ciprofloxacin Impurity | Nitrosamine of the fluoroquinolone class |
| N-Nitroso Paroxetine Impurity | Found in antidepressant formulations |
| N-Nitroso Duloxetine Impurity | Detected in SNRI-based APIs |
| N-Nitroso Phenylephrine Impurity | Impurity in decongestant APIs |
🧪 All materials come with:
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✔️ COA
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✔️ HPLC Purity Report
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✔️ NMR / LC-MS / IR data
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✔️ Custom pack sizes for R&D, stability, or method validation
🚀 Why KarpsChem?
🔬 In-house synthesis for consistency & quality
🧪 Reference standards available immediately
🌍 Global delivery with full documentation
⚙️ Trusted by pharma giants, CROs, and QC labs worldwide
📦 Ready to Order or Need a Custom Quote?
📞 Dr. Amit Nagare
📧 amitnagare@karpschem.in
🌐 www.karpschem.in
📱 +91-9371639228
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