300-355 µm
TAP sind hochsphärische Starterpellets, die aus 100 % Weinsäure bestehen. Sie wirken als pH-Modifikator und als Trägersystem in Formulierungen mit verzögerter Freisetzung von schwach basischen Arzneimitteln. Diese Arzneimittel zeigen typischerweise eine schlechte Löslichkeit in einer Umgebung mit höherem pH-Wert, wie zum Beispiel im unteren Darmtrakt, was durch die Verwendung von TAPs als Starterkerne verbessert werden kann.
Produktinformation (englisch)
| Description | TAP 300-355 | |
| Appearance | white or nearly white particles | visual |
| Physical parameters | ||
| Particle size distribution | 300-355 µm ≥ 75 % | Ph.Eur. |
| Bulk density | 0.8-1.1 g/ml | Ph.Eur. |
| Identification A solution strongly acidic | strongly acidic | Ph.Eur. |
| Identification B reaction of tartrate | positive | Ph.Eur., USP/NF |
| Identification C infra-red absorption | IR-spectrum equivalent reference standard | USP/NF |
| Chemical parameters | ||
| Appearance in solution | clear and not more intensely colored than the reference Y6 | Ph.Eur. |
| Water content | ≤ 0.5 % | Ph.Eur. |
| Loss on drying | ≤ 0.5 % (for information only) | USP/NF |
| Calcium | ≤ 200 ppm | Ph.Eur. |
| Chloride | ≤ 100 ppm | Ph.Eur. |
| Specific optical rotation | +12.0° to +12.8° | Ph.Eur., USP/NF |
| Limit of oxalate | no turbidity | USP/NF |
| Residue on ignition | ≤ 0.05 % | Ph.Eur., USP/NF, JP |
| Sulfate | ≤ 150 ppm | Ph.Eur., USP/NF, JP |
| Heavy metals | ≤ 10 ppm | Ph.Eur., USP/NF, JP |
| Arsenic | ≤ 1 ppm | JP |
| Assay | 99.7 % to 100.5 % | USP/NF |
| Microbiological parameters | ||
| TAMC | less than 1000 CFU/g | Ph.Eur., USP/NF, JP |
| TYMC | less than 100 CFU/g | Ph.Eur., USP/NF, JP |
| E.coli | absence in 1 g sample | Ph.Eur., USP/NF, JP |
Organic solvents in accordance to Ph.Eur. 5.4 and USP <467> (CPMP/ICH/283/95) are not used neither my manufacturing of TAP not by cleaning of equipment.
The starting material of TAP is exclusively of vegetarian origin. A contamination with animal material by manufacturing, storage or shipment in the sealed containers is strictly excluded. Therefore the product is absolute unobjectionable in terms of BSE/TSE risk and according to Ph.Eur. 5.2.8 no BSE/TSE certificate has to be issued by the manufacturer/supplier.
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