Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- INCI Name
- Raw Material Origin
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Applications & Uses
- Markets
- Applications
- Segments
- 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 Sulfated Ash Content max. 1.5 % Current USP/EP/JP Moisture Content max. 5 % Current USP/EP/JP Residue on Ignition max. 1.5 % Current USP/JP Propylene Chlorohydrins Content* max. 0.1 mg/kg E464/JECFA Apparent Viscosity (at 20°C, 2% in water) 75,000 - 140,000 mPa.s Current USP/EP/JP Brookfield Apparent Viscosity (target) 100000 mPa.s - - Microbiological Values
Value Units Test Method / Conditions Escherichia coli* Absent /g Current USP Pseudomonas aeruginosa* Absent /g Current USP NEGATIVE Salmonella* Absent /10g Current USP NEGATIVE Staphylococcus aureus* Absent /g Current USP NEGATIVE Yeast and Mold Count* max. 100 /g Current USP Total Plate Count* max. 100 /g Current USP - Composition
Value Units Test Method / Conditions Hydroxypropoxyl Content 10 - 12 % Current USP/EP/JP Methoxyl Content 22 - 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 - Screen Test
Value Units Test Method / Conditions Particle Size (maximum 63 µm, through 230 U.S.STD. sieve) 65 - 85 % PSM 100669 Particle Size (maximum 149 µm, through 100 U.S.STD. sieve) min. 90 % PSM 100669 Particle Size (maximum 420 µm, through 40U.S.STD. sieve) min. 99 % PSM 100669 - 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 Search Terms
- Chemical Inventories
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Packaging & Availability
- Packaging Type