Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- Country of Origin
- Ingredient Name
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
- Benefits
- Release profile modification of an inert matrix without swelling or dissolving
- Versatility in drug release rates as well as improvements in processing conditions
Applications & Uses
- Markets
- Applications
- Segments
- Applications
- Manufacturing Technology
- Application
- Controlled-Release Hydrophobic Matrices
- Tablet-Binding
Properties
- Physical Form
- Soluble In
- Typical Properties
Value Units Test Method / Conditions Identification* Pass - Current NF NF Identification A* Pass - Current EP Test A - EP Identification B* Pass - Current EP Test B - EP Identification (1)* Pass - Current JP Test - JP Identification (3)* Pass - Current FCC Residual Solvents* Pass - Current USP/EP/JP Loss on Drying max. 2.0 % Current USP Moisture Residue on Ignition max. 0.40 % Current USP/EP/JP Viscosity (at 5%) 6.0 - 8.0 mPa.s Ubbelohde, Current NF - Microbiological Values
Value Units Test Method / Conditions E. coli* Absent /g Current USP Pseudomonas aeruginosa* Absent g Current USP Salmonella* Absent /10g Current USP Staphylococcus aureus* Absent g Current USP Yeast and Mold Count* max. 100 /g Current USP Combined Mold and Yeast Total Bacterial Count* max. 100 /g Current USP Total Aerobic - Composition
Value Units Test Method / Conditions Acidity or Alkalinity* Pass - Current USP/EP/JP Ethoxyl Content 48.0 - 49.5 % Current USP Assay Chloride Content (as NaCl) max. 0.05 % Current USP/EP/JP Aldehydes* max. 100 mg/kg Current USP/EP/JP - Heavy Metals
Value Units Test Method / Conditions Arsenic Content* max. 2 mg/kg Current CHP Lead Content* max. 10 mg/kg Current JP Test - JP Lead Content* max. 3 mg/kg Current FCC - Screen Test
Value Units Test Method / Conditions Particle Size (Mean) 5 - 15 μm PSM 102325 Particle Size max. 140 μm PSM 102325 - Note
- All section names come under PHS.
- The following specifications apply to sealed, unopened containers stored under the recommended conditions for the duration of the shelf life.
- Viscosity: 5% solution in 80/20 Toluene/Alcohol Mixture at 25°C.
- Specification limits apply to the material as packaged in the original containers. They do not apply if the material has been repackaged, improperly stored, or if the package has been opened in an uncontrolled environment.
- *Audit Basis
Regulatory & Compliance
- Certifications & Compliance Search Terms
- Chemical Inventories