Duloxetine Nitroso Impurity 1

Duloxetine Nitroso Impurity 1 is chemically N-(3-hydroxy-3-(thiophen-2-yl)propyl)-N-methylnitrous amide. Duloxetine Nitroso Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Duloxetine Nitroso Impurity 1 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 Duloxetine.

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.

Characterization of impurities formed by interaction of duloxetine HCl with enteric polymers hydroxypropyl methylcellulose acetate succinate and hydroxypropyl methylcellulose phthalate
P J Jansen 1, P L Oren, C A Kemp, S R Maple, S W Baertschi
J Pharm Sci. 1998 Jan;87(1):81-5.
 
Analysis of Duloxetine Hydrochloride and Its Related Compounds in Pharmaceutical Dosage Forms and In Vitro Dissolution Studies by Stability Indicating UPLC
Dantu Durga Rao1,*, Shakil S. Sait1, A. Malleswara Reddy1, Dinesh Chakole1, Y. Ramakoti Reddy2, and K. Mukkanti
Journal of Chromatographic Science, Vol. 48, November/December 2010
 
Development and validation of a stability indicating rp-lc method for the estimation of process related impurities and degradation products of duloxetine hydrochloride and phthalic acid in duloxetine hydrochloride delayed release capsules
Navneet Kumar,1,2 D. Sangeetha,2 Bhupendrasinh Vaghela,1 P. Sunil Reddy,1 and Anuj Raghav
Journal of Liquid Chromatography & Related Technologies, 35:867–881, 2012
 
Determinationof Duloxetine and Its MajorMetabolites in Rabbit Plasma by High-Performance Liquid Chromatography
T. K. Laha1*, S. Sen1, G. Mishra
International Journal of Pharmaceutical Sciences and Drug Research 2015; 7(2): 176-181
 
Development and Validation of UPLC Method for the Determination of Duloxetine Hydrochloride and Its Impurities in Active Pharmaceutical Ingredient
Rohith T1 , Ananda S1,2*, Sajan PG2 and Gowda NM3
J Anal Bioanal Tech Volume 6, Issue 1

• We need to receive valid purchase order with Bill to & Ship to address.
• The quotation ID needs to be mentioned in the purchase order.
• You will receive order confirmation prior to dispatch which need to be verified for any error in product, pack size, prices.

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.

Reach to Us:

• All communication will be addressed to standards@synzeal.com
• SynZeal emphasize on formal communication which is required for smooth processing of the purchase order. It helps multiple people to remain informed about all details.
• For specific purpose, there are below e-mail address to be used.
  • For New products # standards@synzeal.com
  • Order confirmation # order@synzeal.com
  • Open Order Status # projects@synzeal.com
  • Data related Query # support@synzeal.com
  • Invoice Related Query # sales@synzeal.com
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