Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
- Labeling Claims
Applications & Uses
- Markets
- Applications
- Segments
- Applications
- Dosage Form
- Manufacturing Technology
- Product Applications
- Immediate Release Disintegration
- Oral Dispersible Tablets
Properties
- Physical Form
- Physico-Chemical Properties
Value Units Test Method / Conditions Identification Pass - - Sodium Chloride and N-Arachidonylglycine* max. 0.50 % - Degree of Substitution* 0.63 - 0.85 - - Content of Water Soluble Material* 1.0 - 5.5 % - Setting Volume 10.0 - 30.0 mL - pH* 5.9 - 7.0 - - Loss on Drying* max. 6.0 % - 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 Absent - - Pseudomonas aeruginosa Absent - - Staphylococcus aureus Absent - - Salmonella Species Absent - - - Specifications
Value Units Test Method / Conditions Residual Solvent max. 0.01 % - Particle Size Distribution (D10) max. 25 μm Malvern Ld. Particle Size Distribution (D50) 25-55 μm Malvern Ld. Particle Size Distribution (D90) min. 60 μm Malvern Ld. - Heavy Metals
Value Units Test Method / Conditions Heavy Metals max. 0.001 % - - Note
*More restrictive than compendium .
- Nutritional Information
Typical Nutrient Information/100g
US EU/Australia/NZ Estimated Caloric Value 146 Cal 146 Cal/ 610 kJoules
Calories from Fat 0 Cal 0 Cal Total Fat 0 g 0 g Saturated Fat 0 g 0 g Trans-Fat 0 g 0 g Polyunsaturated Fat 0 g 0 g Monounsaturated Fat 0 g 0 g Cholesterol 0 mg 0 g Sodium 7000 mg 7000 mg Salt 0 g 17.50 g Potassium 4 mg 4 mg Total Carbohydrate 73 g 0 g Sugars (Total) 0 g 0 g Added Sugars 0 g 0 g Starch 0 g 0 g Total Dietary Fiber 0 g 73 g Dietary Fiber (Soluble) 0 g 73 g Dietary Fiber (Insoluble) 0 g 0 g Protein 0 g 0 g Vitamin A 0 mcg 0 mcg Vitamin C 0 mg 0 mg Vitamin D 0 mcg 0 mcg Calcium 5 mg 5 mg Iron 0 mg 0 mg Magnesium 0 mg 0 mg Moisture 8 g 8 g Ash 19 g 19 g Organic acid 0 g 0 g
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Quality Standards
Storage & Handling
- Shelf Life
- 3 years
- Storage Conditions
Store at ambient conditions. Keep containers sealed; material is very hygroscopic.Re-evaluation requirements: IFF recommends that after the above re-evaluation date, the customer perform the loss on drying test.