TAP 300-425

300-425 µm

TAP are highly spherical starter pellets consisting of 100 % tartaric acid. They act as a pH modifier and as carrier systems in extended release formulations of weakly basic drugs. These drugs typically show bad solubility in higher pH environment such as in the lower intestinal tract which can be enhanced by the use of TAP as a starter core.

product information

DescriptionTAP 300-425
Appearancewhite or nearly white particlesvisual
Physical parameters
Particle size distribution300-425 µm
≥ 60 %		Ph.Eur.
Bulk density0.8-1.1 g/mlPh.Eur.
Identification
A solution strongly acidic		strongly acidicPh.Eur.
Identification
B reaction of tartrate		positivePh.Eur., USP/NF
Identification
C infra-red absorption		IR-spectrum equivalent reference standardUSP/NF
Chemical parameters
Appearance in solutionclear and not more intensely colored than the reference Y6Ph.Eur.
Water content≤ 0.5 %Ph.Eur.
Loss on drying≤ 0.5 % (for information only)USP/NF
Calcium≤ 200 ppmPh.Eur.
Chloride≤ 100 ppmPh.Eur.
Specific optical rotation+12.0° to +12.8°Ph.Eur., USP/NF
Limit of oxalateno turbidityUSP/NF
Residue on ignition≤ 0.05 %Ph.Eur., USP/NF, JP
Sulfate≤ 150 ppmPh.Eur., USP/NF, JP
Heavy metals≤ 10 ppmPh.Eur., USP/NF, JP
Arsenic≤ 1 ppmJP
Assay99.7 % to 100.5 %USP/NF
Microbiological parameters
TAMCless than 1000 CFU/gPh.Eur., USP/NF, JP
TYMCless than 100 CFU/gPh.Eur., USP/NF, JP
E.coliabsence in 1 g samplePh.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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