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PURITY® 21T - 04730300

1 of 37 products in this brand
PURITY® 21T - 04730300 is a native starch derived from tapioca. It is extra white, free-flowing for use as a filler and disintegrant in a broad range of pharmaceutical applications. It develops viscosity as it is cooked in an aqueous system. Upon cooling, it will be set to a gel-like consistency. Its moisture is not more than 15%. It meets the requirements of USP/ NF.

Chemical Name: Tapioca Starch

CAS Number: 9005-25-8

Functions: Binder, Bulking Agent, Diluent, Filler

Dosage Form: Capsules, Tablets

Labeling Claims: Halal, Kosher, Non-GMO

Certifications & Compliance: FSSC 22000, GMP, Halal, Hazard Analysis Critical Control Point (HACCP), ISO 14001, ISO 22000, ISO 9001, Kosher, Non-GMO Project Verified

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Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions

Features & Benefits

Labeling Claims
Features and Benefits

PURITY® 21T 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 & Uses

Dosage Form

Properties

Physico-Chemical Properties
ValueUnitsTest Method / Conditions
IdentificationComply--
Moisture Contentmax. 14%-
pH (20% w/w slurry)4.5 - 7.0--
Residue on Ignitionmax. 0.5%-
Iron Contentmax. 20ppm-
Oxidising Substancesmax. 20ppm-
Sulfur Dioxide Contentmax. 10ppm-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Plate Countmax. 1000per g-
Yeast and Mold Countmax. 100per g-
Escherichia ColiNegative--
SalmonellaNegative/10g
Coliformsmax. 10per g-
Staphylococcus AureusNegative--
Klebsiella SpeciesNegative--
Pseudomonas SpeciesNegative--
Nutritional Information
ValueUnitsTest Method / Conditions
Calories350.0Kcal/100g-
Calories from Fat1.0Kcal/100g-
Total Fat*max. 0.15g/100g-
Saturated Fat*max. 0.08g/100g-
Trans Fat*max. 0.01g/100g-
Cholesterol0.0mg/100g-
Sodium25.0mg/100g-
Total Carbohydrate87.0g/100g-
Dietary Fiber*max. 1g/100g-
Total Sugars0.0g/100g-
Added Sugars0.0g/100g-
Other Carbohydrate87.0g/100g-
Protein0.25g/100g-
Vitamin D*0.0mcg/100g-
Calcium25.0mg/100g-
Iron0.5mg/100g-
Potassium*max. 10mg/100g-
Note

* Not present in level of quantification.

Regulatory & Compliance

Regulatory Data
  • Source : Tapioca
  • Labeling : Tapioca Starch, NF

Packaging & Availability

Regional Availability
  • Global
Packaging Information

PURITY® 21T is packaged in multi ply kraft paper bags.

Storage & Handling

Shelf Life
24 months
Storage Information/Shelf Life
  • PURITY® 21T should be stored in a clean, dry area at ambient temperature and away from heavily aromatic material.
  • The best before date for PURITY® 21T is 24 months from the date of manufacture.