DICOM SANAQ® LS 004
- Chemical Name
- Lactose, Anhydrous, Starch, Lactose Anhydrous, Starch
DICOM SANAQ® LS 004 have average particle size of 300 - 550 microns. It is a combination of Lactose Monohydrate and Starch (maize). Lactose is water loving and soluble in water, at high compression force it hampers disintegration. Starch has multifunction characters and act as binder as well as disintegrant. Starlose has optimized composition of these two ingredients.
Properties
- Physical Form
- Granules
- Solid
- Pharma and Nutraceuticals Functions
- Binder
- Disintegrant
Product families
Applications
- Oral
- Pharmaceutical Processing
Product Families
- Binders & Disintegrants
Other characteristics
- Brand
- DiCOM SANAQ
- Functions
- Binder, Disintegrant
- Manufacturing Technology
- Direct Compression
- Certifications & Compliance
European Pharmacopeia (Ph. Eur.), GMP, ISO 9001, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Benefits
It's a unique product used as a filler for tablets and capsules: with; Uniform drug distribution; Content uniformity; Better compressibility as it contains suitable proportion of fines; Reduced weight variation; And higher production rates.; Choice of higher average weight; Robust tablet with reduced friability; High bulk density makes this product suitable to formulate high tablet weight / Capsule fill weight in smaller die / capsule size respectively,
- Composition
- Lactose - Starch
- Dosage Form
- Orally Disintegrating Tablets (ODTs)
- Tablets
- Technology
- Pharmaceuticals & Nutraceuticals
- 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
- 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.
- Certifications and Compliance
- European Pharmacopeia (Ph. Eur.)
- GMP
- ISO 9001
- Japan Pharmacopeia (JP)
- National Formulary (NF)
- United States Pharmacopeia (USP)
Technical data
Table 1 of 4
8 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Angle of reposel | 36.22 | º | — |
| Compressibility Index | 21.05 | % | — |
| Hausner's Ratio | 1.27 | — | — |
| LOD (105 OC-3h) | 2.3 | — | NMT 3.0% |
| PSD (Malvern mastersizer) D(10) | 34.1 | — | — |
| PSD (Malvern mastersizer) D(50) | 243 | — | — |
| PSD (Malvern mastersizer) D(90) | 583 | — | — |
| Tapped Density | 0.84 | — | — |
Table 2 of 4
3 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Loss on Drying | max. 3.0 | % | USP/NF / JP / Ph. EUR |
| Bulk Density | 0.5 – 1.0 | g/mL | USP/NF / JP / Ph. EUR |
| pH Value (2% Aqueous Suspension) | 4.0 – 8.0 | — | USP/NF / JP / Ph. EUR |
Table 3 of 4
4 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| 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 |
Table 4 of 4
1 row| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Particle Size | 300 - 500 | μm | Malvem Method |
