Gabapentin Cyclic Impurity

Gabapentin Cyclic Impurity is chemically 1-(Isobutyryloxy)ethyl 3-oxo-2-azaspiro[4.5]decane-2-carboxylate. Gabapentin Cyclic Impurity is supplied with detailed characterization data compliant with regulatory guideline. Gabapentin Cyclic 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 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.

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

• 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
  • Logistic Documents # exports@synzeal.com (For export customer only)
• It is recommended to include standards@synzeal.com always in CC while communicating to other e-mail address.
• SynZeal is committed for promptly responding all communication however if sometime urgent comes us you can use our WhatsApp customer care channel (+91 70690 37751) to reach to customer support team. You can also request call back on WhatsApp and our customer support team will reach to you in defined timeframe.