Shanxian Chemical
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Triethylamine Residual Solvent Limit
On the Regulation of Residual Solvent Limits for Triethylamine
All solvent residues involved in the preparation of pharmaceuticals need to be strictly limited, and triethylamine is also included.
Triethylamine has a special odor and is occasionally used in the production of pharmaceuticals. However, its toxicity and potential harm should not be underestimated. Therefore, setting the residual solvent limit for triethylamine is actually the top priority to ensure drug safety.
According to the Pharmacopoeia and various specifications, the residual solvent limit for triethylamine has been carefully studied and verified by many parties. The setting of this limit takes into account the feasibility of the production process and the limit of human tolerance. Those who produce should follow this limit as a criterion and carefully control it in the process. From the selection of raw materials, to the regulation of reaction conditions, to the separation and purification process, all efforts must be made to stabilize the residual amount of triethylamine within the limit.
If the residual amount of triethylamine exceeds the limit, it may cause drug odor and affect the patient's medication compliance; if it is serious, it may endanger the patient's health and cause many adverse reactions. Therefore, pharmaceutical companies must be well aware of the weight of the residual solvent limit of triethylamine, and keep the drug quality checkpoint with a rigorous state and scientific method to ensure the safety of public medication.
All solvent residues involved in the preparation of pharmaceuticals need to be strictly limited, and triethylamine is also included.
Triethylamine has a special odor and is occasionally used in the production of pharmaceuticals. However, its toxicity and potential harm should not be underestimated. Therefore, setting the residual solvent limit for triethylamine is actually the top priority to ensure drug safety.
According to the Pharmacopoeia and various specifications, the residual solvent limit for triethylamine has been carefully studied and verified by many parties. The setting of this limit takes into account the feasibility of the production process and the limit of human tolerance. Those who produce should follow this limit as a criterion and carefully control it in the process. From the selection of raw materials, to the regulation of reaction conditions, to the separation and purification process, all efforts must be made to stabilize the residual amount of triethylamine within the limit.
If the residual amount of triethylamine exceeds the limit, it may cause drug odor and affect the patient's medication compliance; if it is serious, it may endanger the patient's health and cause many adverse reactions. Therefore, pharmaceutical companies must be well aware of the weight of the residual solvent limit of triethylamine, and keep the drug quality checkpoint with a rigorous state and scientific method to ensure the safety of public medication.
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