Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Name
- Food Ingredients Functions
- Pharma & Nutraceuticals Functions
- CAS No.
- 526-83-0
- EC No.
- 610-885-0
- Technologies
- Product Families
Features & Benefits
- Labeling Claims
- Food Ingredients Features
- Characteristics
- Certain API show pH dependent solubilty which can be a hurdle in the fomulation of extended release dosage foms.
- TAP acts as a pH modifier for substances (weakly basic drugs) with a poor solubility in higher pH that occur in the lower GIT.
- TAP enhances the solublity in this environment.
Applications & Uses
- Markets
- Applications
- Dosage Form
- Food & Nutrition Applications
Properties
- Physical Form
- Appearance
- White or nearly white or beige particles
- Chemical Properties
Value Units Test Method / Conditions Appearance of Solution Clear and not more intensely colored than the reference solution Y Ph. EUR Water Content max. 0.5 % Ph. EUR Loss on Drying max. 0.5 % USP/NF Calcium Content max. 200 ppm Ph. EUR Chloride Content max. 100 ppm Ph. EUR Specific Optical Rotation 12.0 - 12.8 - Ph. EUR / USP/NF Limit of Oxalate No Turbidity - USP/NF Residue on Ignition max. 0.05 % Ph. EUR / USP/NF Sulfate Content No Turbidity - USP/NF Arsenic Content max. 1 ppm JP Assay Content 99.7 - 100.5 % USP/NF - Typical Properties
Value Units Test Method / Conditions Bulk Density 0.80 - 1.1 g/ml Ph. EUR Particle Size 425 - 600 µm Ph. EUR A Solution Strongly Acidic Strongly Acidic - Ph. EUR B Reactions of Tartrates Positive - Ph. EUR / USP/NF - Microbiological Values
Value Units Test Method / Conditions Total Aerobic Microbial Count max. 1000 CFU/g Ph. EUR/ USP/NF/JP Total Yeast and Mold Count max. 100 CFU/g Ph. EUR/ USP/NF/JP Escherichia Coli (in 1 g Sample) Absent - Ph. EUR/ USP/NF/JP - C Infrared Absorption
IR-spectrum (ATR) equivalent reference standard