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stability testing of active pharmaceutical ingredients and finished pharmaceutical products

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In the realm of pharmaceuticals, intermediates play a crucial role in the synthesis of active pharmaceutical ingredients (APIs), which are the biologically active components of drugs. The term intermediate refers to a chemical compound that is formed during the synthesis of a desired product but does not itself have pharmacological activity. These intermediates are essential for the efficient and innovative development of medications, as they serve as building blocks in the multi-step chemical processes that lead to the final drug formulation.

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The molecular structure of N,N-dimethylurea can be visualized as having a central carbon atom bound to two nitrogen atoms and one oxygen atom, characteristic of urea. The presence of two methyl groups permits N,N-dimethylurea to exhibit unique chemical behavior, influencing its reactivity and interactions with other chemical species. It is a colorless, crystalline solid that is soluble in water, alcohols, and various organic solvents, allowing it to be integrated into a wide range of formulations and processes. The compound typically has a melting point of about 116 °C and a boiling point of approximately 180 °C.

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3. Atorvastatin


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