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Ingredientpharm TAP 700

Ingredientpharm TAP 700 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

Technical Data Sheet
  • TypeDocument Name
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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

Features
  • Ready-made spherical particles
  • Defined Particle size and shape
  • 100 % pelletized Tartaric Acid (Ph. Eur., USP/NF, JP), no binders
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 (600-800 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