UNI-PURE® F - 03451006
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.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Binder
- Bulking Agent
- Diluent
- Filler
Product families
Applications
- Oral
Product Families
- Binders & Disintegrants
- Carriers & Bulking Agents
- Fillers & Diluents
Other characteristics
- Brand
- UNI-PURE
- Functions
- Binder, Bulking Agent, Diluent, Filler
- Dosage Form
- Capsules, Tablets
- Capsules
- Tablets
- Labeling Claims
- Halal, Kosher, Non-GMO
- 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)
- Note
- * Not present at level of quantification.
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Shelf LIfe
- 24 Months
- Technology
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Bags
- Drums
- Regulatory Data
- CAS Number
- 9005-25-8
- United States Meets USP/NF requirements for Corn Starch NF. Labeling : Corn Starch NF
- Meets USP/NF requirements for Corn Starch NF.
- Labeling
- Corn Starch NF
- Canada CFDA Regulation
- Not applicable
- CFDA Regulation
- Not applicable
- Storage Condition
UNI-PURE ® F Corn Starch NF should be stored in a clean, dry area at ambient temperature and away from heavily aromatic material.
- Chemical Inventories
- DSL (Canada)
- TSCA (USA)
- Benefits and Features
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.
- Packaging Information
UNI-PURE ® F Corn Starch NF is packaged with a net weight of 50 lb bag, or 200 lb fiber drum.
- Manufacturing Technology
- Capsule Filling
- Direct Compression
- Wet Granulation
- Certifications and Compliance
- European Pharmacopeia (Ph. Eur.)
- FSSC 22000
- GFSI Certified
- Halal
- ISO 22000
- Japan Pharmacopeia (JP)
- Kosher
- National Formulary (NF)
Technical data
Table 1 of 4
8 rows| Characteristic | Value | Unit |
|---|---|---|
| pH | 4 - 7 | — |
| Identification | Passes | — |
| Foreign Matter | Passes | — |
| Loss on Drying | max. 15 | % |
| Sulfated Ash Content | max. 0.6 | % |
| Iron | max. 10 | ppm |
| Oxidizing Substances | max. 20 | ppm |
| Sulfur Dioxide | max. 10 | ppm |
Table 2 of 4
6 rows| Characteristic | Value | Unit |
|---|---|---|
| Total Plate Count | max. 1,000 | per g |
| Yeast and Molds Count | max. 100 | per g |
| Total Coliforms | max. 9 | per g |
| Escherichia coli | Negative | — |
| Salmonella | Negative | /10g |
| Staphylococcus aureus | Negative | — |
Table 3 of 4
18 rows| Characteristic | Value | Unit |
|---|---|---|
| Calories | 353 | — |
| Calories From Fat | max. 1 | — |
| Total Fat * | max. 0.1 | g/100g |
| Saturated Fat | 0 | g/100g |
| Trans Fat | 0 | g/100g |
| Cholesterol * | 0 | mg/100g |
| Sodium | 33 | mg/100g |
| Total Carbohydrates | 88 | g/100g |
| Dietary Fiber | 0 | g/100g |
| Total Sugars * | max. 0.1 | g/100g |
| Added Sugars | 0 | g/100g |
| Other Carbohydrates | 88 | g/100g |
Table 4 of 4
1 row| Characteristic | Value | Unit |
|---|---|---|
| Through U.S.S. #100 Mesh | min. 95 | % |
