Ashland has introduced vialose sucrose, a high purity sucrose for parenteral formulations that’s designed to protect and shield biologic molecules in injectables. Vialose sucrose meets the lowest levels of endotoxins (<0.2 g/EU) and meets NF, EP, JP, BP and ChP monograph specifications. 

The addition of sucrose expands Ashland’s portfolio of vialose high purity sugar excipients, which includes trehalose dihydrate. These sugars are used in medicines as lyoprotectants and for protein stabilization in monoclonal antibodies, antibody-drug conjugates (ADCs), vaccines, peptides and stem cells. The company is planning to bring vialose mannitol to market later in 2026.

“We’re excited to introduce vialose sucrose, our latest premier performance sugar for use in biologic medicines,” said Shawn Branning, global business line owner – cyclodextrins and biopharma, Ashland. “Our high purity sucrose, used to stabilize proteins and act as a lyoprotectant, is tested to meet the lowest levels of endotoxins and ChP monograph specifications, making it an ideal choice for use in biologic formulations.” 

Additionally, to reduce the risk of nitrosamines in drug products, Ashland offers excipients with low nitrite levels to help mitigate associated risks and improve patient safety. By providing detailed nitrite specifications, Ashland enables customers to make informed decisions and enhance their own quality control measures. 

Plasdone low nitrite povidone and polyplasdone LN crospovidone grades offer a nitrite specification of <100ppb with results reported on every CoA, setting a new benchmark for transparency and regulatory compliance. Benecel xr/xrf low nitrite hypromellose offers a nitrite specification of <200ppb with results reported on every CoA. 

“Our newly introduced excipients with significantly reduced nitrite levels—including plasdone low nitrite povidone, polyplasdone LN crospovidone and benecel low nitrite hypromellose—help our customers mitigate nitrosamine formation in their final drug products,“ says Caroline Cooreman, director strategy and business development, OSD, Ashland.