Acarbose EP Impurity B

Isolation and preparation methods of acarbose impurities
By Liang, Xianrui; Zhang, Huichen; He, Xiaoai; Wu, Hui; Su, Weike
From Zhejiang Gongye Daxue Xuebao (2017), 45(3), 289-293
 
An innovative method for estimation of metformin HCl and acarbose pharmaceutical products and separation of metformin impurities by RP-​HPLC
By Shaikh, Jalil K.; M., Ajay Babu; Farooqui, Mazahar; Syed, Ummul Khair Asema
From International Journal of PharmTech Research (2020), 13(2), 71-79
 
Development and Validation of a Stability-​Indicating HPLC Method for the Determination of Acarbose in Pharmaceutical Dosage Forms
By Azam Sadat Montazeri; Mohammadi, Ali; Adib, Noushin; Naeemy, Ali
From Journal of Analytical Chemistry (2018), 73(9), 910-916

Acarbose EP Impurity B is chemically (1R,4R,5S,6R)-4,5,6-Trihydroxy-2-(hydroxymethyl)cyclohex-2-enyl 4-O-[4,6-dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-enyl]amino]-α-D-glucopyranosyl]-α-D-glucopyranoside (as per EP); (1R,4R,5S,6R)-4,5,6-Trihydroxy-2-(hydroxymethyl)cyclohex-2-enyl 4-O-[4,6-dideoxy-4-{[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-enyl]amino}-α-d-glucopyranosyl]-α-d-glucopyranoside (as per USP). It is also known as Acarbose USP Impurity B. Acarbose EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Acarbose EP Impurity B 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 Acarbose.

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.