Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Technologies
- Product Families
- Composition
- MCC - Lactose
Features & Benefits
- Product Highlights
- Mixtures with high compressibility,superior diluition properties and fast disitegrating time. The purpose of the excipient is to aid processing during manufacture, enhance stability or bioavailability.
Applications & Uses
- Markets
- Applications
- Dosage Form
- Manufacturing Technology
- Application Fields
LS 004
Diluent - Disintegrant
ML 011
Diluent - Binder
SP 204
Designed for moisture sensitive APIs and where alkaline conditions are needed for stability purpose
SP 205
Designed for moisture sensitive and low bulk density and fluffy API’s formulations.
SP 206
Designed for moisture sensitive and low bulk density and fluffy API’s formulations
SR 300
Designed for modified release, matrix type of tablets
Properties
- Typical Properties
- Physico-Chemical Properties
- Microbiological Values
- Particle Size Distribution
Value | Units | Test Method / Conditions | |
Compressibility Index | 17.91 | % | — |
PSD (Malvern mastersizer) D(10) | 34.3 | — | — |
PSD (Malvern mastersizer) D(50) | 252 | — | — |
PSD (Malvern mastersizer) D(90) | 579 | — | — |
Residue on Ignition | 0.52 | — | — |
Value | Units | Test Method / Conditions | |
Loss on Drying | max. 3.0 | % | USP/NF / JP / Ph. EUR |
Hausner Ratio | 1.2 | — | — |
Bulk Density | 0.5 – 1.0 | g/mL | USP/NF / JP / Ph. EUR |
Repose Angle | max. 35° | — | USP/NF / JP / Ph. EUR |
pH Value (2% Aqueous Suspension) | 4.0 – 8.0 | — | USP/NF / JP / Ph. EUR |
Value | Units | Test Method / Conditions | |
TAMC | max. 1000 | CFU/g | USP/NF / JP / Ph. EUR |
TYMC | max. 100 | CFU/g | USP/NF / JP / Ph. EUR |
E. Coli, Pseudomonas Aeruginosa | Negative in 10 g sample | — | USP/NF / JP / Ph. EUR |
St. Aureus, Salmonella Species | Negative in 10 g sample | — | USP/NF / JP / Ph. EUR |
Value | Units | Test Method / Conditions | |
Particle Size | 250 - 600 | μm | Malvem Method |
Regulatory & Compliance
- Certifications & Compliance
- Grade