Gabapentine Impurity 9

SZ CAT No:	SZ-G001027
CAS No	NA
Mol.F.	C21H35NO11
Mol.Wt.	477.5
Inv. Status	Custom Synthesis

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Chemical Name: 2-((2,3,5-Trihydroxy-4-((3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2-yl)methyl)-2-azaspiro[4.5]decan-3-one compound with 2-((2,3-dihydroxy-5-(hydroxymethyl)-4-((3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydrofuran-2-yl)methyl)-2-azaspiro[4.5]decan-3-one (1:1)

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Smiles: OC1C(OC2C(O)COC(CN3C(CC4(CCCCC4)C3)=O)(O)C2O)OC(CO)C(O)C1O.OC5C(OC6C(CO)OC(CN7CC8(CCCCC8)CC7=O)(O)C6O)OC(CO)C(O)C5O

Application of UHPLC for determination of Gabapentin drug substance and its related impurities
Ramesha.B1 2 , K. R. Venugopala Reddy 2*, Nischith.H.M 1, Amith Kumar M.K 1, Vinitha.K.V 1 and Vidyanand Ankolekar
Journal of Pharmacy Research 2012,5(8),4437-4442

Development and validation of reversed-phase high-performance liquid chromatography method for gabapentin and its related substances in capsule dosage form and excipient compatibility studies
Afroz patan*, alekhya k, vijey aanandhi m
103Asian J Pharm Clin Res, Vol 11, Special Issue 4, 2018, 102-109

Determination of gabapentin in bulk drug and in pharmaceutical dosage form by hplc method
B. udaykumar raob, f. maqdoomb and anna pratima nikaljea
J. Chil. Chem. Soc., 54, Nº 4 (2009), págs. 424-427.

A Novel Method for Assessing Drug Degradation Product Safety Using Physiologically-Based Pharmacokinetic Models and Stochastic Risk Assessment
Hoa q. nguyen,1 stephen d. stamatis,2 lee e. kirsch1
Nguyen, Stamatis, and Kirsch, journal of pharmaceutical sciences 104:3101–3119, 2015

Gabapentine Impurity 9 is chemically 2-((2,3,5-Trihydroxy-4-((3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydro-2H-pyran-2-yl)methyl)-2-azaspiro[4.5]decan-3-one compound with 2-((2,3-dihydroxy-5-(hydroxymethyl)-4-((3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)tetrahydrofuran-2-yl)methyl)-2-azaspiro[4.5]decan-3-one (1:1). Gabapentine Impurity 9 is supplied with detailed characterization data compliant with regulatory guideline. Gabapentine Impurity 9 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 Gabapentin.

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.

Gabapentine Impurity 9

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Inv. Status	: Custom Synthesis