Modified Starch, Corn

USP-NF, Ph. Eur.

Description

An Excellent Multi-compendial film former for gelatin-free softgel capsules. It is designed to work with other hydrocolloids

Key benefits

Good film formation and gel strength
Provides clear film, stability, protection, and efficient release for your Veggie Softgels
It is compatible with a variety of drug actives
EIP Index available

Functionalities

Film Forming
Gelatin Replacer

Dosage form

Softgel Capsule

EIP Documentation updated in Dec. 24

Product documentation

This product has 27 documents

Download selected

	Document name	Description	Download
	UNI-PURE® GA P100 EIP Index	Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
	UNI-PURE® GA P100 Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	UNI-PURE® GA P100 Release Specification	Shows the quality standards of a material according to a list of tests required
	UNI-PURE® GA P100 MSDS	MSDS: Material Safety Data Sheet
	UNI-PURE® GA P100 Label	Displays the label graphic
	UNI-PURE® GA P100 TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	UNI-PURE® GA P100 Source of origin	The country of origin of the excipient
	UNI-PURE® GA P100 Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	UNI-PURE® GA P100 Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	UNI-PURE® GA P100 Heavy metal	Reports the detection and estimation of the Heavy Metals
	UNI-PURE® GA P100 Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	UNI-PURE® GA P100 Nitrosamine	A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
	UNI-PURE® GA P100 Allergen	Related to Regulation or specific allergens evaluated
	UNI-PURE® GA P100 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® GA P100 Microanalytical	Report which shows Microbial limit test results
	UNI-PURE® GA P100 Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	UNI-PURE® GA P100 GRAS	GRAS: Generally Recognized as Safe
	UNI-PURE® GA P100 Storage condition	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	UNI-PURE® GA P100 Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	UNI-PURE® GA P100 Genotoxic free	Declaration if the material is free from Genotoxic Impurities
	UNI-PURE® GA P100 Country of origin	It is the country of manufacture or production
	UNI-PURE® GA P100 Aflatoxins	Declaration that the material is free from Aflatoxins
	UNI-PURE® GA P100 Melamine	Declaration that confirm if the material is free of melamine contamination
	UNI-PURE® GA P100 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® GA P100 Stability	To show that the stability meets the excipient specification
	UNI-PURE® GA P100 Halal	Halal indicates that this product is permitted and fit for consumption according to Islamic law
	UNI-PURE® GA P100 Kosher	Certifies that this ingredient and the process of preparing it complies with orthodox kosher

UNI-PURE® GA P100