Mirtazapine EP Impurity C

Mirtazapine EP Impurity C is chemically (14bRS)-2-methyl-3,4,10,14b-tetrahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-1(2H)-one (as per EP) ; 2-Methyl-3,4,10,14b-tetrahydrobenzo[c]pyrazino[1,2-a]pyrido[3,2-f]azepin-1(2H)-one (as per USP). It is also known as Mirtazapine USP Related Compound C ; Mirtazapine Lactam. Mirtazapine EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Mirtazapine EP Impurity C can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Mirtazapine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.

Determination of mirtazapine in spiked human plasma and tablets by first derivative spectrofluorimetric method
Rasha M.Youssef
Saudi Pharmaceutical Journal Volume 18, Issue 1, January 2010, Pages 45-49
 
Development and Validation of a Reversed-Phase HPLC Method for Separation and Simultaneous Determination of Process-Related Substances of Mirtazapine in Bulk Drugs and Formulations
R. Nageswara Rao* and A. Narasa Raju
Journal of Chromatographic Science, Vol. 47, March 2009; 223-230
 
Simultaneous Determination of Mirtazapine and its Three Main Impurities by a High Performance Thin Layer Chromatography/ Densitometry Method
T. Sheshashena Reddy and P. Sita Devi
Journal of Liquid Chromatography & Related Technologiesw, 31: 1204–1212, 2008

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• The quotation ID needs to be mentioned in the purchase order.
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Delivery time:

• In Stock product will dispatch in 24 h after receipt of purchase order. It usually take 2-3 days to receive products in India and 5-6 working days for export customer depending on destination.
• The custom synthesis products would be dispatched as per quoted timeline.

Shipping:

• There will be 100 USD towards logistic charges per shipment if we used our FedEx. There will not be any charge if we use your FedEx/DHL Account. Depending on part shipment logistic charges will be added.
• For countries dispatch by courier is not allowed where product would be dispatched in cargo mode as per agreed Inco term.

Additional Charges:

• Controlled substance charges need to follow as per quotation. The specific inputs are required for controlled substance because regulatory status will differ based on destination.
• Cold Shipment Charges needs to be considered as per quotation.
• For ice pack there are no additional charges.

Technical Queries:

• All technical queries need to raise within 15 days of product receipt. Thereafter it will be our resolved at our discretion.

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• All communication will be addressed to standards@synzeal.com
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