In the food and beverage industry, Sodium Starch Glycolate is used as a gelling agent, thickener, and stabilizer. It finds applications in various sectors, including bakery, confectionery, and dairy products, where it improves texture, stability, and shelf life. The growing demand for processed and convenience foods, along with the increasing consumer preference for clean-label and natural ingredients, drives its use in these industries. Additionally, its role in enhancing the health benefits of dietary fiber and its use in functional foods further boosts its demand in the food and beverage sector[4][5].
The creation of Sodium Starch Glycolate involves a chemical process known as carboxymethylation. This process begins with the reaction of starch, which can be derived from various sources such as corn, potato, sweet potato, or cassava, with sodium hydroxide and mono chloro acetic acid. The starch is first mixed with a solution of sodium hydroxide and yellow soda ash in an alcoholic solution, such as methyl alcohol, ethanol, or propyl alcohol, which has a water content of 0-20%. The mono chloro acetic acid, also dissolved in an alcoholic solution, is then added to this mixture. The carboxymethylation reaction is carried out at a temperature range of 30-90 ℃ over a period of 0.5-5 hours[1][2][3].
After the reaction is complete, the mother liquor is removed through water washing, and the solid is washed with an alcoholic solution to remove any impurities. The product is then dried using methods such as abrasive dusting or cyclone drying to obtain a white or faint yellow loose fine powder. This final product, Sodium Starch Glycolate, has good stability, high viscosity at low substitution values, and excellent water solubility, making it suitable for use as a disintegrant, suspending agent, and gelling agent in pharmaceutical formulations[1][4][2].
The safety profile of Sodium Starch Glycolate for human consumption is generally favorable. It is considered a safe and non-hazardous substance when used as a pharmaceutical excipient. Sodium Starch Glycolate has low toxicity and is not absorbed in significant amounts in the intestinal tract. It does not pose appreciable risks to human health under current use scenarios, and no daily allowable intake has been set due to its non-toxic and non-irritating nature. However, it is important to note that it can be a dust hazard, and precautions should be taken to prevent dust generation, especially in industrial settings. Despite this, there are no cumulative adverse effects associated with its use, either alone or in combination with other substances[1][2].
Regarding potential contamination risks, Sodium Starch Glycolate is sourced from potatoes, which reduces the likelihood of certain types of contamination. It is highly unlikely to contain heavy metals or pesticides, as it is derived from a natural source that is not typically associated with these contaminants. Additionally, the manufacturing process for pharmaceutical-grade Sodium Starch Glycolate involves stringent quality control measures, including air quality control, which minimizes the risk of cross-contamination with other substances, such as gluten or other allergens. Pathogen risks are also mitigated due to the strict hygiene and processing standards in pharmaceutical manufacturing facilities. Overall, the risk of contamination by heavy metals, pesticides, or pathogens is considered very low for Sodium Starch Glycolate[1][3][4].
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