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

EIP Documentation updated in Nov. 24

Product documentation

This product has 26 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 Country of origin	It is the country of manufacture or production
	PURITY® 21T Aflatoxins	Declaration that the material is free from Aflatoxins
	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