DICOM SANAQ® ML 011
- Chemical Name
- Cellulose, Microcrystalline, Lactose, Anhydrous, Cellulose Microcrystalline, Lactose Anhydrous
Off white free flowing granules.
Properties
- Physical Form
- Granules
- Solid
- Pharma and Nutraceuticals Functions
- Binder
- Diluent
Product families
Applications
- Oral
- Pharmaceutical Processing
Product Families
- Binders & Disintegrants
- Fillers & Diluents
Other characteristics
- Brand
- DiCOM SANAQ
- Functions
- Binder, Diluent
- Dosage Form
- Orally Disintegrating Tablets (ODTs), Tablets
- Orally Disintegrating Tablets (ODTs)
- Tablets
- 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
- Composition
- MCC - Lactose
- 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.
- Manufacturing Technology
- Direct Compression
- 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
5 rows| Characteristic | Value | Unit |
|---|---|---|
| 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 | — |
Table 2 of 4
5 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| 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 |
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 | 250 - 600 | μm | Malvem Method |
