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UNI-PURE® F - 03451006

1 of 10 products in this brand
UNI-PURE® F - 03451006 is a native corn starch. It is extra-white and free-flowing with not more than 15% moisture. It can be used as a Filler/Disintegrant for both hard-shell capsules and tablet dosage forms. When cooked in an aqueous system, it develops viscosity and sets to a firm gel upon cooling. The multi-compendial UNI-PURE® F meets the requirements of USP/NF, Ph. Eur., and JPE Pharmacopeias.

Chemical Name: Corn Starch

CAS Number: 9005-25-8

Functions: Binder, Bulking Agent, Diluent, Filler

Dosage Form: Capsules, Tablets

Labeling Claims: Halal, Kosher, Non-GMO

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FSSC 22000, GFSI Certified, Halal, ISO 22000, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), Non-GMO Project Verified, United States Pharmacopeia (USP)

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Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
9005-25-8
EC No.
232-679-6

Features & Benefits

Labeling Claims
Features and Benefits

UNI-PURE® F Corn Starch NF is characterized by its extra white color. When cooked in an aqueous system, it develops viscosity and sets to a firm gel upon cooling.

Applications & Uses

Dosage Form

Properties

Physical Form
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
pH4 - 7--
IdentificationPasses--
Foreign MatterPasses--
Loss on Dryingmax. 15%-
Sulfated Ash Contentmax. 0.6%-
Ironmax. 10ppm-
Oxidizing Substancesmax. 20ppm-
Sulfur Dioxidemax. 10ppm-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Plate Countmax. 1,000per g-
Yeast and Molds Countmax. 100per g-
Total Coliformsmax. 9per g-
Escherichia coliNegative--
SalmonellaNegative/10g
Staphylococcus aureusNegative--
Nutritional Information
ValueUnitsTest Method / Conditions
Calories353--
Calories From Fatmax. 1--
Total Fat *max. 0.1g/100g-
Saturated Fat0g/100g-
Trans Fat0g/100g-
Cholesterol *0mg/100g-
Sodium33mg/100g-
Total Carbohydrates88g/100g-
Dietary Fiber0g/100g-
Total Sugars *max. 0.1g/100g-
Added Sugars0g/100g-
Other Carbohydrates88g/100g-
Protein *0.2g/100g-
Vitamin D *0mcg/100g-
Calcium *15mg/100g-
Iron *max. 0.2mg/100g-
Potassiummax. 10mg/100g-
Ash Contentmax. 0.1g/100g-
Screen Test
ValueUnitsTest Method / Conditions
Through U.S.S. #100 Meshmin. 95%-
Note

* Not present at level of quantification.

Regulatory & Compliance

Chemical Inventories
Regulatory Data
  • CAS Number : 9005-25-8
  • United States
    • Meets USP/NF requirements for Corn Starch NF.
    • Labeling : Corn Starch NF
  • Canada
    • CFDA Regulation : Not applicable

Packaging & Availability

Packaging Type
Regional Availability
  • Global
Packaging Information

UNI-PURE ® F Corn Starch NF is packaged with a net weight of 50 lb bag, or 200 lb fiber drum.

Storage & Handling

Shelf Life
24 Months
Storage Conditions

UNI-PURE ® F Corn Starch NF should be stored in a clean, dry area at ambient temperature and away from heavily aromatic material.