Direct Compression Mannitol

USP-NF, Ph. Eur., BP, JPE, IP

Description

An engineered powder designed to meet specific particle size and density requirements. Our direct compression product minimizes segregation during manufacturing for consistent and high-quality results.

MANNITAB is a trademark of the Ingredion and MB Sugars Joint Venture

Key benefits

High density compactable powder for tableting
Excellent flow, reliable disintegration and compression performance
Average mean particle size 400 μ approx.
EIP available

Functionalities

Binder

Dosage form

Tablets

EIP Documentation updated in Nov.25

Product documentation

This product has 21 documents

Download selected

	Document name	Description	Download
	MANNITAB™ DC4 Export Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	MANNITAB™ DC4 Export Release Specification	Shows the quality standards of a material according to a list of tests required
	MANNITAB™ DC4 MSDS	MSDS: Material Safety Data Sheet
	MANNITAB™ DC4 TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	MANNITAB™ DC4 Source of origin	The country of origin of the excipient
	MANNITAB™ DC4 Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	MANNITAB™ DC4 Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	MANNITAB™ DC4 Heavy metal	Reports the detection and estimation of the Heavy Metals
	MANNITAB™ DC4 Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	MANNITAB™ DC4 Allergen	Related to Regulation or specific allergens evaluated
	MANNITAB™ DC4 Gluten free	The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
	MANNITAB™ DC4 Microanalytical	Report which shows Microbial limit test results
	MANNITAB™ DC4 Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	MANNITAB™ DC4 Storage condition	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	MANNITAB™ DC4 Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	MANNITAB™ DC4 Genotoxic	Declaration if the material is free from Genotoxic Impurities
	MANNITAB™ DC4 Country of origin	It is the country of manufacture or production
	MANNITAB™ DC4 Aflatoxins	Declaration that the material is free from Aflatoxins
	MANNITAB™ DC4 Melamine	Declaration that confirm if the material is free of melamine contamination
	MANNITAB™ DC4 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.
	MANNITAB™ DC4 Halal	Halal indicates that this product is permitted and fit for consumption according to Islamic law

MANNITAB™ DC4