Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 63-42-3
- EC No.
- 200-559-2
- Technologies
Features & Benefits
- Benefit Claims
Applications & Uses
- Markets
- Dosage Form
Properties
- Appearance
- White crystalline powder
- Soluble in
- Water
- Insoluble in
- Ethanol (96%)
- Specifications
Value | Units | Test Method / Conditions | |
Absorbance (Proteins and Light Absorbing Impurities, [A] 1%, 1 cm at 210 to 220 nm) | max. 0.25 | - | - |
Absorbance (Proteins and Light Absorbing Impurities, [A] 1%, 1 cm at 270 to 300 nm) | max. 0.07 | - | - |
Absorbance (Proteins and Light Absorbing Impurities, [A] 10%, 1 cm at 400 nm) | max. 0.04 | - | - |
Acidity or Alkalinity (at ml 0.1 M NaOH) | max. 0.4 | - | - |
Bile Tolerant Gram Negative Bacteria | Absent | per 10g | - |
Burkholderia Cepacia | Absent | per 10g | - |
Endotoxins Content | max. 5 | EU/g | - |
Escherichia Coli | Negative | in 10g | - |
Heavy Metals | max. 5 | ppm | USP |
Loss on Drying | max. 0.5 | % | - |
Particle Size Distribution (X₁₀) | 4 - 10 | µm | Laser Diffraction Sympatec, Dry Dispersion |
Particle Size Distribution (X₅₀) | 35 - 65 | µm | Laser Diffraction Sympatec, Dry Dispersion |
Particle Size Distribution (X₉₀) | 110 - 160 | µm | Laser Diffraction Sympatec, Dry Dispersion |
Pseudomonas Aeruginosa | Absence | per 10g | - |
Purity | min. 99.7 | % | HPLC |
Residue on Ignition / Sulphated Ash | max. 0.1 | % | - |
Salmonella | Negative | in 10g | - |
Specific Optical Rotation (at [α] 20D, Anhydrous Substance) | 54.4 - 55.9 | degree | - |
Staphylococcus Aureus | Absent | per 10g | - |
Total Aerobic Microbial Count | max. 10 | CFU/g | - |
Total Yeast and Molds Count | max. 10 | CFU/g | - |
Water Content | 4.5 - 5.5 | % | KF Method |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Residual Solvents
No class 1, 2, 3 solvents are used during production. (CPMP/ICH/283/95 + CVMP/VICH/502/99)
- Certifications
- EXCIPACT certified (GMP)
- ISO 9001 and ISO 22000 certified
- Following IPEC cGMP
- On-site Batch testing & Batch release
- Certified animal Rennet-free raw materials
Technical Details & Test Data
- Particle Size Distribution
PSD (Laser diffraction
Sympatec, dry dispersion)Specifications (μm) X10 4 to 10 X50 35 to 65 X90 110 to 160 SSA 0.8 m2/g X10 : 6 μm | X50 : 48 μm | X90 : 142 μm *
*PSD laser diffraction (Sympatec, dry), indicative.
- PSD Comparison (Laser diffraction, Sympatec, Dry Dispersion)
- Product Customization Possibilities
- Particle size/shape/surface customization through process adjustment
- Blending of several products
- Joint product development
- Functionality related characteristics testing
- Low, medium and high volume manufacturing scales
- Additional microbial & physical properties testing
- Packaging in cartons drums/Plastic boxes/Carton with aluminum foil
Packaging & Availability
- Packaging Type
Storage & Handling
- Shelf Life
- 12 Months
- Storage Information
Store in original unopened packaging, in a dry and odor free place.