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
- Physical Properties
Value Units Test Method / Conditions pH (at 2%) 5 - 8 - CURRENT USP/EP/JP - Typical Properties
Value Units Test Method / Conditions Moisture (Loss on Drying) max. 5.0 % USP/EP/JP Sulfated Ash max. 1.5 % CURRENT USP/EP/JP Loss on Drying max. 5.0 % CURRENT USP/EP/JP Nitrite Content max. 200 μg/kg PSM 300040 Residue on Ignition max. 1.5 % USP/JP Propylene Chlorohydrins* max. 0.1 mg/kg E464 Apparent Viscosity (at 20°C, 2% in water) 80 - 120 mPa·s CURRENT USP/EP/JP, Brookfeild - Microbiological Values
Value Units Test Method / Conditions Apparent Viscosity (Target) 100 mPa.s Target E. coli* Absent /g USP Yeasts and Molds Count max. 100 /g CURRENT USP Total Count Pseudomonas aeruginosa* Absent /g USP Total Plate Count max. 100 /g CURRENT USP Total Aerobic Salmonella* Absent /10g USP Staphylococcus aureus* Absent /g USP Yeasts and Molds* max. 100 /g USP - Composition
Value Units Test Method / Conditions Hydroxypropoxyl Content 7.5 - 9.5 % CURRENT USP/EP/JP Methoxyl Content 22 - 24 % CURRENT USP/EP/JP - Residual Solvents
Value Units Test Method / Conditions Propylene Glycol max. 0.1 % - Dipropylene Glycol max. 0.1 % - Tripropylene Glycol max. 0.1 % - Dipropylene Glycol Monomethyl Ether max. 0.1 % - Tripropylene Glycol Monomethyl Ether 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 Partcle Size (through 230 USS sieve, <63 micron) 50.0 - 80.0 % PSM 100669 Partcle Size (through 100 USS sieve, <149 micron) min. 90.0 % PSM 100669 Partcle Size (through 40 USS sieve, <420 micron) min. 99.0 % 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
- Chemical Inventories