PURE C - CORN STARCH USP/NF (MAIZE STARCH)
Corn Starch for pharmaceutical solid dosage forms
PURE C is a free – flowing corn starch NF for use in pharmaceutical products. PURE C is a corn starch characterized by its extra white color. PURE C starches can be used as filler/diluents for both capsule and tablet dosage forms. Additionally PURE C can also be used as disintegrants in tablet systems. This product is recommended whenever a starch with a high degree of whiteness and free-flowing properties is desired.
PRODUCT PROFILE
WET GRANULATION BINDER
PURE C provides excellent binding properties in wet granulation applications. PURE C when cooked in an aqueous system, it develops viscosity and sets to firm gel upon cooling and provides strong binding or adhesive properties. Concentration depends on the level of solvent, shear conditions of the granulator, and the temperature of the granulation. Furthermore, the binding properties of PURE C are retained after conventional, fluid-bed, and high-shear granulations.
BINDER SELECTION PROCESS
PURE C provides excellent binding properties in wet granulation applications. PURE C when cooked in an aqueous system, it develops viscosity and sets to firm gel upon cooling and provides strong binding or adhesive properties. Concentration depends on the level of solvent, shear conditions of the granulator, and the temperature of the granulation. Furthermore, the binding properties of PURE C are retained after conventional, fluid-bed, and high-shear granulations.
DISINTEGRANTION PROFILE
PURE C can be used as a disintegrant in pharmaceutical applications. A 2-10% usage level is recommended for its disintegrant effect in tablet formulations. The disintegrant profile at 2% level as a function of tablet compression force is shown in figure.
PRODUCT SPECIFICATIONS
PHYSICAL AND CHEMICAL CHARACTERISTICS
| COLOR | Whitish |
| FORM | Fine powder |
| MOISTURE (PURE C) | 12% maximum |
| GRANULATION | |
| THRU USSS#100 | 95% |
| THRU USSS#200 | 85% |
| IDENTIFICATION | Passes test |
| PH | 4.5-7.0 |
| RESIDUE ON IGNITION | 0.5% maximum |
| OXIDIZING SUBSTANCES | Passes test |
| 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
Corn Starch NF/ Corn Starch USP
STORAGE AND HANDLING
PURE C is packaged in 2-ply, Kraft paper bags pe liner inside with a net weight of 25 kg. It is recommended that PURE C be stored in a clean, dry area at ambient temperature and away from aromatic material. The shelf life for PURE C is 24 months from the date of receipt.