EH-TABLET - TAPIOCA STARCH USP/NF
Tapioca Starch for pharmaceutical solid dosage forms
Tapioca Starches for pharmaceutical solid dosage forms EH-TABLET is an extra white, free-flowing Tapioca Starch NF for use in solid dosage form.
PRODUCT PROFILE
EH-TABLET is a tapioca starch characterized by its extra white color. When cooked in an aqueous system, it develops viscosity and sets to a firm gel upon cooling.
Applications:
EH-TABLET is used as binder, filler and disintegrant in a wide variety of food and pharmaceutical applications. The superior color of EH-TABLET is particulary desirable for the manufacture of many tablets.
This product is recommended whenever a starch with high degree of whiteness and free-flowing properties is desired.
EH-TABLET meets the National Formulary standards for Tapioca Starch NF.
PRODUCT SPECIFICATIONS
PHYSICAL AND CHEMICAL CHARACTERISTICS
| COLOR | Whitish |
| FORM | Fine powder |
| MOISTURE (PURE C) | 12% maximum |
| GRANULATION | |
| THRU USSS#100 | 99% |
| IDENTIFICATION | Passes test |
| PH | 4.5-7.0 |
| RESIDUE ON IGNITION | 0.5% maximum |
| OXIDIZING SUBSTANCES | Passes test |
| IRON | 20 ppm Maximum |
| ORGANIC VOLATILE | Complies |
| IMPURITIES | Standards |
| SULFUR DIOXIDE | 0.001% maximum |
| *when packed |
MICROBIOLOGICAL SPECIFICATION
| TOTAL PLATE COUNT | < 1000 CFU/GM |
| YEAST & MOLD | < 100 CFU/GM |
| E.COLI | Negative |
| SAMONELLA | Negative |
| S.AUREUS | Negative |
LABEL DECLARATION
Tapioca Starch NF/ Tapioca Starch USP
STORAGE AND HANDLING
EH-TABLET is packaged in 3-ply, Kraft paper bags with a net weight of 25 kg. It is recommended to be stored in a clean, dry area at ambient temperature and away from aromatic material. The shelf life is 24 months from the date of receipt.