Process development and scale-up of PPAR α/γ Dual agonist lobeglitazone sulfate (CKD-501)

Organic Process Research and Development

Volumn 11, Issue 2, 2007, Pages 190-199

  Lee, Hong Woo ^a   Ahn, Joong Bok ^b   Kang, Sung Kwon ^a   Ahn, Soon Kil ^a   Ha, Deok Chan ^b  

^a Process Research and Development Laboratory   (South Korea)

^b Korea University   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 34247258462     PISSN: 10836160     EISSN: None     Source Type: Journal    
DOI: 10.1021/op060087u     Document Type: Article

References (40)

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36. Performed at three different conditions: (i) accelerated stability: 45 ± 2 °C/75%±5% relative humidity, (ii) long term stability: 25 ±2°C/60% ± 5% relative humidity, (iii) photostability: ambient temperature and humidity/fluorescence lamp exposure (light source: 10,000 Lux), and analyzed by XRD, Karl Fischer, HPLC purity and assay, DSC, and TGA.
37. Long-term chemical stability observed at ambient temperature and humidity in aluminum foil package storage for two years.
38. A mechanical grinding stability experiment and a six-month stability study under accelerated storage conditions (45±2°C/75%±5% relative humidity monitoring by HPLC) were performed after the preparation of the GMP batch confirmed the selection of the lobeglitazone sulfate (CKD-501) as the development candidate.
39. 6S by EA.
40. Methanol is being classified as a class 2 (<3000 ppm) solvent in ICH guidelines.