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
- Key Benefits
- Excellent compaction properties
- Very good flowability
- Very good blending properties (Low dose formulations)
Applications & Uses
- Markets
- Manufacturing Technology
- Applications
- Direct compression
- Tablets
- Effervescent tablets
- Hard capsules, sachets
- Direct compression
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 | — | — |
| Escherichia Coli | Negative | in 1g | — |
| Heavy Metals | max. 5 | ppm | USP |
| Loss on Drying | max. 0.5 | % | — |
| Particle Size Distribution (max. 100 µm) | 30 - 65 | % | Air Jet Sieve |
| Particle Size Distribution (max. 250 µm) | min. 95 | % | Air Jet Sieve |
| Particle Size Distribution (max. 45 µm) | max. 15 | % | Air Jet Sieve |
| 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 | — |
| Total Aerobic Microbial Count | max. 100 | CFU/g | — |
| Total Yeast and Molds Count | max. 50 | 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
(Air Jet Sieve)Specifications (%)
% < 45 µm ≤ 15 % < 100 µm 30 - 65 % < 250 µm ≥ 95 Spray dried process gives spherical particles with a narrow Particle Size Distribution that flow very well
PSD (Malvern Laser Diffraction, Indicative Values)
X10 : 46 µm, X50 : 98 µm, X90 : 205 µm
- Tabletability
EXCIPRESS TM SD2L exhibits excellent compaction properties . It is an excipient of choice for Direct C ompression formulations.
- Flowability
According to flowability index measured by Flodex , EXCIPRESS TM SD2L exhibits a “very good” flowability.
- Poured Density : 0.62 g/mL
- Tapped Density : 0.69 g/mL
- Carr’s Index : 10 %
- Hausner Ratio : 1.11
- Scanning Electron Microscopy
- Process Flow Chart
- Product Performance Characteristics
1 2 3 4 5 Compressibility Very low Low Good High Very high Flowability (Carr’s index) More than 26 21 to 25 16 to 20 11 to 15 0 to 10 Cohesiveness (Hausner ratio) 1.00 to 1.11 1.12 to 1.18 1.19 to 1.25 1.26 to 1.34 ≥ 1.35 Poured density (g/ml) Less than 0.50 0.50 to 0.59 0.60 to 0.69 0.70 to 0.79 ≥ 0.80 X50 0 to 20 21 to 50 51 to 100 101 to 200 ≥ 200 Span (PSD)* Less than 1.0 1.0 to 1.4 1.5 to 1.9 2 to 2.4 ≥ 2.5 SSA (m2/g) ≤ 0.10 0.10 to 0.40 0.41 to 0.80 0.81 to 1.40 ≥ 1.41 * Span = (X90 - X10) / X50
Packaging & Availability
- Packaging Type
Storage & Handling
- Shelf Life
- 18 Months
- Storage Information
Store in original unopened packaging, in a dry and odor free place.