Fully Pregel starch, corn

USP-NF

Description

Binder for your wet granulation formulations This product is for Legacy customers only For new customers, please check our UNI-PURE® WG 220

Key benefits

Improves granulation flow and compressibility
Simplifies process and reduces cost
Dry blend binder, eliminates solution preparation
EIP Index available

Functionalities

Binder

Dosage form

Tablets

EIP Documentation updated in May 25

Product documentation

This product has 26 documents

Download selected

	Document name	Description	Download
	NATIONAL® 78-1551 (China) EIP Index	Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
	NATIONAL® 78-1551 (India) Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	NATIONAL® 78-1551 (India) Release Specification	Shows the quality standards of a material according to a list of tests required
	NATIONAL® 78-1551 (India) MSDS	MSDS: Material Safety Data Sheet
	NATIONAL® 78-1551 (India) Label	Displays the label graphic
	NATIONAL® 78-1551 (India) TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	NATIONAL® 78-1551 (India) Source of origin	The country of origin of the excipient
	NATIONAL® 78-1551 (India) Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	NATIONAL® 78-1551 (India) Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	NATIONAL® 78-1551 (India) Heavy metal	Reports the detection and estimation of the Heavy Metals
	NATIONAL® 78-1551 (India) Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	NATIONAL® 78-1551 (India) Nitrosamine	A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
	NATIONAL® 78-1551 (India) Allergen	Related to Regulation or specific allergens evaluated
	NATIONAL® 78-1551 (India) Gluten free	The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
	NATIONAL® 78-1551 (India) Microanalytical	Report which shows Microbial limit test results
	NATIONAL® 78-1551 (India) Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	NATIONAL® 78-1551 (India) GRAS	GRAS: Generally Recognized as Safe
	NATIONAL® 78-1551 (India) Storage condition	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	NATIONAL® 78-1551 (India) Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	NATIONAL® 78-1551 (India) Genotoxic free	Declaration if the material is free from Genotoxic Impurities
	NATIONAL® 78-1551 (India) Country of origin	It is the country of manufacture or production
	NATIONAL® 78-1551 (India) Aflatoxins	Declaration that the material is free from Aflatoxins
	NATIONAL® 78-1551 (India) Melamine	Declaration that confirm if the material is free of melamine contamination
	NATIONAL® 78-1551 (India) 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.
	NATIONAL® 78-1551 (India) Stability	To show that the stability meets the excipient specification
	NATIONAL® 78-1551 (India) Halal	Halal indicates that this product is permitted and fit for consumption according to Islamic law

NATIONAL® 78-1551 (India)