N-Acetyl Zonisamide
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E-mail: anna@molcoo.com
Product Information
Product Number: Z010004
English Name: N-Acetyl Zonisamide
English Alias: N-((benzo[d]isoxazol-3-ylmethyl)sulfonyl)acetamide
CAS Number: 68936-43-6
Molecular Formula: C10H10N2O4S
Molecular Weight: 254.26
Advantages: As a reference standard for N-Acetyl Zonisamide, it has a clear chemical structure, and its purity is strictly tested, ≥98%. It has good stability and uniformity. Under normal storage conditions (2 - 8°C, protected from light and sealed), it can remain stable for a long time without easy decomposition or deterioration. It can be used as an accurate reference substance for the detection of N-Acetyl Zonisamide impurities in zonisamide bulk drugs and formulations, ensuring the accuracy and repeatability of detection results, meeting the high standards of drug research, development, production, and quality supervision, and providing a reliable basis for drug quality control.
Applications:
Quality Testing: Used to establish and optimize the detection methods for N-Acetyl Zonisamide impurities in zonisamide, such as high-performance liquid chromatography (HPLC) and liquid chromatography - mass spectrometry (LC - MS). By accurately determining the impurity content, the quality of drugs can be evaluated to meet the standards.
Process Optimization: During the synthesis of zonisamide, monitor the content of N-Acetyl Zonisamide impurities in real time. Adjust reaction conditions (such as temperature, time, raw material ratio) and improve the synthesis process to reduce the generation of this impurity and improve the purity and quality of bulk drugs.
Stability Studies: In drug stability tests (accelerated tests, long-term tests), track the changes in the content of N-Acetyl Zonisamide impurities, analyze its impact on drug stability, and provide data support for determining the shelf life and storage conditions of drugs.
Regulatory Compliance: Help pharmaceutical companies meet the requirements of domestic and international drug regulatory agencies (such as FDA, EMA, NMPA) for drug impurity limits. During the drug registration and application process, provide accurate and reliable impurity detection data to ensure that products meet regulatory standards.
Background Description: Zonisamide is a drug used to treat neurological diseases such as epilepsy. During its production process, impurities such as N-Acetyl Zonisamide may be generated due to incomplete raw material reactions and side reactions. The presence of these impurities may affect the efficacy of zonisamide and even pose potential hazards to human health. To ensure the safety and effectiveness of patients' medication and meet the requirements of drug regulation, strict control of impurities in zonisamide is essential. As one of the key impurities of zonisamide, in-depth research and precise control of N-Acetyl Zonisamide help to improve the quality standard system of zonisamide and enhance drug quality.
Research Status:
Detection Technology: Currently, the HPLC - UV method is mainly used to detect N-Acetyl Zonisamide impurities. By optimizing conditions such as the type of chromatographic column, the composition of the mobile phase, and the detection wavelength, effective separation and accurate quantification of impurities can be achieved, with a detection limit of up to 0.05%. The application of LC - MS technology has further improved the sensitivity and accuracy of detection, enabling more precise identification of impurity structures.
Formation Mechanism: Research shows that N-Acetyl Zonisamide may originate from acetylation side reactions during the synthesis of zonisamide, or from reactions involving acetyl-related substances in the raw materials. Through a detailed analysis of the synthesis route, the key factors affecting the generation of this impurity have been clarified, providing a theoretical basis for process improvement.
Safety Evaluation: The toxicological research on N-Acetyl Zonisamide is gradually being carried out. Preliminary experimental data show that this impurity may affect cell activity at certain concentrations. Therefore, strict limits have been set for it in drug quality standards to ensure the safety of clinical drug use.
NOTE！
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
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