Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Applications & Uses
- Markets
- Applications
- Dosage Form
- Manufacturing Technology
Properties
- Physical Form
- Soluble In
- Physical Properties
Value Units Test Method / Conditions pH (at 2%) 5 - 8 - Current USP/EP/JP - Typical Properties
Value Units Test Method / Conditions Residue on Ignition max. 1.5 % Current USP/JP Apparent Viscosity (at 20°C, 2% in water) 75,000 - 140,000 mPa.s Current USP/EP/JP Brookfield Sulfated Ash Content max. 1.5 % Current USP/EP/JP Moisture Content max. 5 % Current USP/EP/JP Propylene Chlorohydrins Content* max. 0.1 mg/kg E464/JECFA Apparent Viscosity (target) 100000 mPa.s - Nitrite Content max. 200 μg/kg PSM 300040 - Microbiological Values
Value Units Test Method / Conditions Salmonella* Absent /10g Current USP NEGATIVE Pseudomonas aeruginosa* Absent /g Current USP NEGATIVE Escherichia coli* Absent /g Current USP Yeast and Mold Count* max. 100 /g Current USP Total Plate Count* max. 100 /g Current USP Staphylococcus aureus* Absent /g Current USP NEGATIVE - Composition
Value Units Test Method / Conditions Hydroxypropoxyl Content 7 - 12 % Current USP/EP/JP Methoxyl Content 19 - 24 % Current USP/EP/JP - Residual Solvents
Value Units Test Method / Conditions Propylene Glycol Content max. 0.1 % - Dipropylene Glycol Content max. 0.1 % - Tripropylene Glycol Content max. 0.1 % - Dipropylene Glycol Monomethyl Ether Content max. 0.1 % - Tripropylene Glycol Monomethyl Ether Content max. 0.1 % - - Heavy Metals
Value Units Test Method / Conditions Arsenic Content* max. 0.1 mg/kg E464 Cadmium Content* max. 0.1 mg/kg E464 Mercury Content* max. 0.1 mg/kg E464 Lead Content* max. 0.1 mg/kg E464 - Note
- PHS - All section names come under PHS
- * Tests tagged or noted as "Audit Basis" [AB] are conducted on a frequency that is established for each test. Audit testing is justified by knowledge of the manufacturing process, process control, use of dedicated equipment and raw material specifications.
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories