Duloxetine Lactose Adduct Impurity

SZ CAT No:	SZ-D001065
CAS No	NA
Mol.F.	C30H39NO11S
Mol.Wt.	621.7
Inv. Status	Custom Synthesis

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Chemical Name: (2S,3R,4R,5R,6R)-2-(((2R,3S,5R)-4,5-Dihydroxy-2-(hydroxymethyl)-6-(methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)amino)tetrahydro-2H-pyran-3-yl)oxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Smiles: O[C@H]1[C@@H](CO)O[C@@H](O[C@@H]2[C@@H](CO)OC(N(C)CCC(C3=CC=CS3)OC4=C(C=CC=C5)C5=CC=C4)[C@H](O)C2O)[C@H](O)[C@@H]1O

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

Duloxetine Lactose Adduct Impurity is chemically (2S,3R,4R,5R,6R)-2-(((2R,3S,5R)-4,5-Dihydroxy-2-(hydroxymethyl)-6-(methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)amino)tetrahydro-2H-pyran-3-yl)oxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol. Duloxetine Lactose Adduct Impurity is supplied with detailed characterization data compliant with regulatory guideline. Duloxetine Lactose Adduct Impurity 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.