Analytical Specifications for Lactobionic Acid Tests Specifications: Appearance : White to off- white crystalline powder, odorless. Solubility…
Analytical Specifications for Lactobionic Acid Tests Specifications: Appearance : White to off- white crystalline powder, odorless. Solubility : Soluble in water, Freely soluble in boiling water Identification : Shall pass the test Specific optical rotation : + 22.80 to + 28.80 Clarity of 10% w/v solution in water at 250C : Clear or not more opalescent than the reference suspension. Colour of 10% w/v solution in water at 250C : Colourless or not more intensely coloured than the colour comparison solution. pH of 10% w/v solution in water : Between 1.0 and 3.0 Calcium : Max. 500 ppm Reducing sugars : Max. 1.0% (w/w) Arsenic : Max. 2 ppm Iron : Max. 80 ppm Chloride : Max. 400 ppm Heavy metals : Max. 10 ppm Sulphate : Max. 400 ppm Silicate (as silicon di oxide) : Max. 215 ppm Residue on ignition : Max. 0.1% (w/w) Loss on drying : Max. 5.0% w/w Assay (on dried basis) : 97.0% - 103.0% w/w Particle Size Distribution Passing thru’ U.S 35# : More than 70 % w/w Bulk density (Loose) : 300-800 kg/ m3 Microbial Limit Tests: Bacterial Endotoxin Test : Max.100 EU /g Total viable aerobic count : Max. 100 CFU/g Total fungus : Max.50 cfu / g Enterobacteriaceae : Absent in 1g E.Coli : Absent in 10 g Salmonella : Absent in 10 g Staphylococcus aureus : Absent in 10 g Pseudomonas aeruginosa : Absent in 10 g 1. In house specs, Method of testing available on request. 2. MSDS - Available on request. Other: Shelf life : 3 years from date of manufacturing. Storage condition : Preserve in a sealed container at temperature between 20-250C. Manufacturing Condition : WHO cGMP approved. Quality Certification : ISO, USFDA, EDQM, cGMP, EU-Compliance, HACCP, KOSHER – StarK PAREVE Status, HALAL & ICH-Q7A. Packaging Units : Products can be supplied in packaging ranging from 20 kgs – 50 kgs Packing : Packing Material options include HDPE Bags Plastic Drums, Fiber Drums, Fiber Kegs, High Resistance Paper Sacks and High Density Carton with inner HDPE liner sealed air tight. Dated : 25th September 2006
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