DICOM SANAQ® SP 204
Off white free flowing granules.
Properties
- Physical Form
- Granules
- Solid
- Pharma and Nutraceuticals Functions
- Binder
- Diluent
Identification
- Chemical Name
Cellulose, Microcrystalline, Magnesium Peroxide, Sodium Carboxymethyl Starch, Starch, Starch, Pregelatinized; Cellulose Microcrystalline; Magnesium Peroxide; Sodium Carboxymethyl Starch; Starch; Starch Pregelatinized
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
- Benefits
Uniform Alkaline protection from all the side.; Compression at high speed with uniform weight and quality attributes.; Enhanced Stability for acid labile APIs.; Better product quality, robust tablet with reduced friability.; Reduced tolling damage because of indirect contact and protection by other excipients in combination. No special coating required on tools...; High bulk density makes this product suitable to formulate high tablet weight capsule fill weight in smaller die / capsule size respectively.; Large Surface area of Light Magnesium Oxide gives enhanced protection / stability to acid labile APIs from a 360° alkaline microenvironment.; Handling and processing with Light Magnesium Oxide is challenging.; DICOM SANAQ-DC SP204 designed in a way for easy handling and maximum protection.; Improper die filling Segregation tendency (leads to weight variation / non-uniform alkaline microenvironment/ unstable formulation); Light magnesium oxide is very fluffy and difficult to process directly; Tooling damage, in some cases. Special coating required on tools.
- Composition
MCC - MgO2 -Starch -Pregelatizend starch -Sodium starch glycolate
- 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 3
5 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Loss on Drying | max. 3.0 | % | USP/NF / JP / Ph. EUR |
| Hausner Ratio | 1.16 | — | — |
| 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 2 of 3
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 3 of 3
1 row| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Particle Size | 300 - 600 | μm | Malvem Method |
