Native starch, Corn

USP-NF, Ph. Eur., JPE

Description

Multi-compendial and ultra low-moisture starch suitable for moisture-sensitive actives

Key benefits

NMT 2% Moisture
Inhibits the caking of hygroscopic materials
Can be used as a binder in Wet Granulation (when cooked)
EIP Index available

Functionalities

Filler
Diluent
Bulking agent
Binder
Disintegrant

Dosage form

Tablets
Hard Capsules

EIP Documentation updated in Dec. 24

Product documentation

This product has 26 documents

Download selected

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