Loteprednol Impurity 1

Loteprednol Impurity 1 is chemically (8S,9S,10R,13S,14S,17R)-17-((ethoxycarbonyl)oxy)-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylic 2-methoxyacetic anhydride. Loteprednol Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Loteprednol 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 Loteprednol.

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.

Potential Use of Cyclodextrin Complexes for Enhanced Stability, Anti-​inflammatory Efficacy, and Ocular Bioavailability of Loteprednol Etabonate
By Soliman, Osama Abd El-Aazeem; Mohamed, Elham Abdel Monem; El-Dahan, Marwa Salah; Khatera, Nabil Abdullah Ali
From AAPS PharmSciTech (2017), 18(4), 1228-1241
 
Determination of edetate disodium dihydrate in loteprednol and tobramycin ophthalmic suspension by RP-​HPLC
By Xue, Qi; Yang, Longhua
From Zhongguo Yaoye (2012), 21(1), 24-25

An HPLC method to evaluate purity of a steroidal drug, loteprednol etabonate
By Yasueda, Shin-ichi; Higashiyama, Masayo; Shirasaki, Yoshihisa; Inada, Katsuhiro; Ohtori, Akira
From Journal of Pharmaceutical and Biomedical Analysis (2004), 36(2), 309-316

• 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
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  • Invoice Related Query # sales@synzeal.com
  • Logistic Documents # exports@synzeal.com (For export customer only)
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