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Ingredientpharm TAP 500-600

Ingredientpharm TAP 500-600 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.

Chemical Name: Tartaric Acid

CAS Number: 526-83-0

Functions: Buffers & pH Stabilizer, Carrier

Dosage Form: Pellets

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Synonyms: (S,S)-(-)-Tartaric Acid, D-(-)-Tartaric Acid, D-Threaric Acid

    Knowde Enhanced TDS

    Identification & Functionality

    Chemical Name

    Tartaric Acid

    Pharma & Nutraceuticals Functions

    Buffers & pH Stabilizer,

    Carrier

    CAS No.
    526-83-0
    EC No.
    610-885-0
    Technologies

    Pharmaceuticals & Nutraceuticals

    Product Families

    Pharmaceuticals & Nutraceuticals — Excipients

    Carriers & Bulking Agents,

    Formulation & Processing Aids

    Features & Benefits

    Product Highlights

    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.

    Applications & Uses

    Markets

    Healthcare & Pharma

    Applications

    Healthcare & Pharma — Drug Delivery & Care Solutions

    Other Drug & Care Solutions

    Dosage Form

    Pellets

    Properties

    Appearance
    white or nearly white particles
    Physical Properties
    ValueUnitsTest Method / Conditions
    Particle size distribution (500-600 µm)min. 75%Ph.Eur.
    Bulk density0.8-1.1g/mlPh.Eur.
    Identification (Solution strongly acidic)strongly acidic—Ph.Eur.
    Identification (Reaction of tartrate)positive—Ph.Eur., USP/NF
    Identification (Infra-red absorption)IR-spectrum equivalent reference standard—USP/NF
    Appearance in solutionClear and not more intensely colored than the reference Y6—Ph.Eur.
    Water contentmax. 0.5%Ph.Eur.
    Loss on drying (for information only)max. 0.5%USP/NF
    Calciummax. 200ppmPh.Eur.
    Chloridemax. 100ppmPh.Eur.
    Specific optical rotation12.0° to +12.8°—Ph.Eur., USP/NF
    Limit of oxalateno turbidity—USP/NF
    Residue on ignitionmax. 0.05%Ph.Eur., USP/NF, JP
    Sulfatemax. 150ppmPh.Eur., USP/NF, JP
    Heavy metalsmax. 10ppmPh.Eur., USP/NF, JP
    Arsenicmax. 1ppmJP
    Assay99.7 - 100.5%USP/NF
    Microbiological Values
    ValueUnitsTest Method / Conditions
    TAMCmax. 1000CFU/gPh.Eur., USP/NF, JP
    TYMCmax. 100CFU/gPh.Eur., USP/NF, JP

    Regulatory & Compliance

    Certifications & Compliance

    European Pharmacopeia (Ph. Eur.),

    Japan Pharmacopeia (JP),

    National Formulary (NF),

    United States Pharmacopeia (USP)

    Grade

    Pharma Grade