Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Applications & Uses
- Markets
- Applications
- Segments
- Applications
- Dosage Form
- Manufacturing Technology
Properties
- Physical Form
- Physico-Chemical Properties
Value Units Test Method / Conditions Identification Pass - - Sodium Chloride and Sodium Glycolate max. 0.50 % - Degree of Substitution 0.63 - 0.85 - - Content of Water Soluble Material 1.0 - 10.0 % - Settling Volume 10.0 - 30.0 mL - pH 5.5 - 7.0 - - Loss on Drying max. 6.0 % - Heavy Metals max. 0.001 % - Sulfated Ash Content 14.0 - 28.0 % - - Microbiological Values
Value Units Test Method / Conditions Total Aerobic Count max. 100 cfu/g - Total Fungi (Yeast and Mold) max. 20 cfu/g - E. coli Not Detected - - Pseudomonas aeruginosa Not Detected - - Staphylococcus aureus Not Detected - - Salmonella Species Not Detected - - - Nutritional Information
Value Units Test Method / Conditions Moisture Content max. 8 g/100g - Total Energy 0 KJ/100g - Total Fat 0.0 g/100g - Saturated Fat 0.0 g/100g - Polyunsaturated Fat 0.0 g/100g - Monounsaturated Fat 0.0 g/100g - Cholesterol 0.0 g/100g - Sodium approx. 5.5 g/100g - Potassium max. 4 mg/100g - Calcium Content max. 5 mg/100g - Total Carbohydrate 0.0 g/100g - Dietary Fiber min. 85 g/100g - Protein 0.0 g/100g - Vitamin A 0.0 IU/100g - Vitamin C 0.0 mg/100g - Iron Content max. 1 mg/100g - - Note
This product meets the requirements for Residual Solvents in the United States Pharmacopeia <467> and complies with the ICH Guide Q3C for Residual Solvents.
Regulatory & Compliance
- Certifications & Compliance Search Terms
- Quality Standards
Storage & Handling
- Shelf Life
- 3 years
- Shelf Life Information
Storage conditions: Store at ambient conditions. Keep containers sealed; material is very hygroscopic. Re-evaluation date: three (3) years from date of manufacture, if storage conditions stated above are observed. Re-evaluation requirements: DuPont recommends that after the above re-evaluation date, the customer perform the loss on drying test.