Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 526-83-0
- EC No.
- 610-885-0
- Technologies
Features & Benefits
- Product Highlights
Organic solvents in accordance to Ph.Eur. 5.4 and USP <467> (CPMP/ICH/283/95) are not used neither my manufacturing of TAP not by cleaning of equipment. The starting material of TAP is exclusively of vegetarian origin. A contamination with animal material by manufacturing, storage or shipment in the sealed containers is strictly excluded. Therefore the product is absolute unobjectionable in terms of BSE/TSE risk and according to Ph.Eur. 5.2.8 no BSE/TSE certificate has to be issued by the manufacturer/supplier.
Applications & Uses
- Markets
- Dosage Form
Properties
- Appearance
- white or nearly white particles
- Physical Properties
- Microbiological Values
Value | Units | Test Method / Conditions | |
Particle size distribution (425-500 µm) | min. 75 | % | Ph.Eur. |
Bulk density | 0.8-1.1 | g/ml | Ph.Eur. |
Identification (Solution strongly acidic) | strongly acidic | — | Ph.Eur. |
Identification (Reaction of tartrate) | positive | — | Ph.Eur., USP/NF |
Identification (Infra-red absorption) | IR-spectrum equivalent reference standard | — | USP/NF |
Appearance in solution | Clear and not more intensely colored than the reference Y6 | — | Ph.Eur. |
Water content | max. 0.5 | % | Ph.Eur. |
Loss on drying (for information only) | max. 0.5 | % | USP/NF |
Calcium | max. 200 | ppm | Ph.Eur. |
Chloride | max. 100 | ppm | Ph.Eur. |
Specific optical rotation | 12.0° to +12.8° | — | Ph.Eur., USP/NF |
Limit of oxalate | no turbidity | — | USP/NF |
Residue on ignition | max. 0.05 | % | Ph.Eur., USP/NF, JP |
Sulfate | max. 150 | ppm | Ph.Eur., USP/NF, JP |
Heavy metals | max. 10 | ppm | Ph.Eur., USP/NF, JP |
Arsenic | max. 1 | ppm | JP |
Assay | 99.7 - 100.5 | % | USP/NF |
Value | Units | Test Method / Conditions | |
TAMC | max. 1000 | CFU/g | Ph.Eur., USP/NF, JP |
TYMC | max. 100 | CFU/g | Ph.Eur., USP/NF, JP |
Regulatory & Compliance
- Certifications & Compliance
- Grade