
ARL9068 2892260-32-9
CAS Number: | 937-40-6 |
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Product Code: | ARL8730 |
Molecular Formula/Molecular Weight: | / 150.18 |
Purity: | 95% |
HSN Number: | 29221990 |
Note: For research use only, not for direct human use.*
Pack Size | Unit Price | Stock in Mumbai WH | Stock in Hyderabad WH | Quantity |
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Description : N-Nitroso-N-methylbenzylamine is a nitrosamine impurity derived from the secondary amine found in Rivaroxaban. It is a well-characterized reference standard that complies with the stringent regulatory requirements for nitrosamines established by the USP, EMA, JP, and BP. This standard is crucial for various applications, including analytical method development, method validation (AMV), and quality control (QC), especially in the manufacture of Rivaroxaban. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). The use of this nitrosamine reference standard enables accurate detection limit determination, impurity quantification, and ensures compliance with FDA and EMA safety thresholds for trace nitroso impurities in pharmaceutical products.
Purity(HPLC) | min. 95% |
Physical State (20 deg.C) | Solid |
Storage Temperature | 15°C |
Conditions to Avoid | Moisture and heat sensitive |
Storage Condition | Store under inert gas, in a cool, dry, and well-ventilated area, keeping the container tightly closed to prevent contamination. |
Packaging and Container | Glass Bottle |
Pictogram : |
N-Nitroso-N-methylbenzylamine (NBMA), also referred to as NMBzA, is a nitrosamine compound widely used in the pharmaceutical industry for impurity analysis. It serves as a reference standard for determining detection limits and quantifying trace levels of nitrosamine impurities in drug products. Its use helps ensure compliance with safety thresholds established by regulatory authorities such as the FDA and EMA.
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This is a sample COA and may not represent a recently manufactured lot of the product.