Native Starch, Tapioca

USP-NF

Description

Extra-white Tapioca starch. This free-flowing filler when cooked in an aqueous system develops viscosity and sets to a firm gel upon cooling

Key benefits

Extra-white
Moisture: NMT 15%
Promotes Disintegration
EIP Index available

Functionalities

Filler
Diluent
Bulking agent

Dosage form

Tablets
Hard Capsules

Files

Product documentation

This product has 25 documents

Download selected

	Document name	Description	Download
	PURITY® 21T EIP Index	Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
	PURITY® 21T Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	PURITY® 21T Release Specification	Shows the quality standards of a material according to a list of tests required
	PURITY® 21T MSDS	MSDS: Material Safety Data Sheet
	PURITY® 21T Label	Displays the label graphic
	PURITY® 21T TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	PURITY® 21T Source of origin	The country of origin of the excipient
	PURITY® 21T Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	PURITY® 21T Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	PURITY® 21T Heavy metal	Reports the detection and estimation of the Heavy Metals
	PURITY® 21T Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	PURITY® 21T Nitrosamine	A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
	PURITY® 21T Allergen	Related to Regulation or specific allergens evaluated
	PURITY® 21T Gluten-free	The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
	PURITY® 21T Microanalytical	Report which shows Microbial limit test results
	PURITY® 21T Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	PURITY® 21T GRAS	GRAS: Generally Recognized as Safe
	PURITY® 21T Storage condition	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	PURITY® 21T Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	PURITY® 21T Genotoxic	Declaration if the material is free from Genotoxic Impurities
	PURITY® 21T Viral microbiological	Viral safety information
	PURITY® 21T Melamine	Declaration that confirm if the material is free of melamine contamination
	PURITY® 21T Shelf life	The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
	PURITY® 21T Halal	Halal indicates that this product is permitted and fit for consumption according to Islamic law
	PURITY® 21T Kosher	Certifies that this ingredient and the process of preparing it complies with orthodox kosher