Spray Dried Mannitol

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

Description

Direct compression Mannitol with a narrow distribution well suited for Chewable and ODT formulations.

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

Key benefits

Free-flowing powder with excellent compactability
High solubility in water enhances dissolution
Approx. 170 μ average mean particle size
EIP Index available

Functionalities

Binder

Dosage form

Tablets

EIP Documentation updated in Dec. 24

Product documentation

This product has 32 documents

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	Document name	Description	Download
	MANNITAB™ SD2 EIP Index	Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
	MANNITAB™ SD2 Export Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	MANNITAB™ SD2 Domestic Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	MANNITAB™ SD2 Export Release Specification	Shows the quality standards of a material according to a list of tests required
	MANNITAB™ SD2 Release Specification \| Spanish	Shows the quality standards of a material according to a list of tests required
	MANNITAB™ SD2 Domestic Release Specification	Shows the quality standards of a material according to a list of tests required
	MANNITAB™ SD2 MSDS	MSDS: Material Safety Data Sheet
	MANNITAB™ SD2 MSDS \| Spanish	Información básica sobre el material y/o sustancia química determinada (Documento en español)
	MANNITAB™ SD2 Domestic Label	Displays the label graphic
	MANNITAB™ SD2 Label	Displays the label graphic
	MANNITAB™ SD2 TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	MANNITAB™ SD2 Source of origin	The country of origin of the excipient
	MANNITAB™ SD2 Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	MANNITAB™ SD2 Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	MANNITAB™ SD2 Heavy metal	Reports the detection and estimation of the Heavy Metals
	MANNITAB™ SD2 Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	MANNITAB™ SD2 Nitrosamine	A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
	MANNITAB™ SD2 Allergen	Related to Regulation or specific allergens evaluated
	MANNITAB™ SD2 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™ SD2 Microanalytical	Report which shows Microbial limit test results
	MANNITAB™ SD2 Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	MANNITAB™ SD2 GRAS	"GRAS" is an acronym for Generally Recognized As Safe
	MANNITAB™ SD2 Storage condition	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	MANNITAB™ SD2 Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	MANNITAB™ SD2 Genotoxic free	Declaration if the material is free from Genotoxic Impurities

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MANNITAB™ SD2