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. 100 μ average mean particle size
EIP Index available

Functionalities

Binder

Dosage form

Tablets

EIP Documentation updated in Dec. 24

Product documentation

This product has 29 documents

Download selected

	Document name	Description	Download
	MANNITAB™ SD1 EIP Index	Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
	MANNITAB™ SD1 Export Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	MANNITAB™ SD1 Domestic Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	MANNITAB™ SD1 Export Release Specification	Shows the quality standards of a material according to a list of tests required
	MANNITAB™ SD1 Domestic Release Specification	Shows the quality standards of a material according to a list of tests required
	MANNITAB™ SD1 MSDS	MSDS: Material Safety Data Sheet
	MANNITAB™ SD1 Export Label	Displays the label graphic
	MANNITAB™ SD1 Domestic Specimen Label	Displays the label graphic
	MANNITAB™ SD1 TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	MANNITAB™ SD1 Source of origin	The country of origin of the excipient
	MANNITAB™ SD1 Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	MANNITAB™ SD1 Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	MANNITAB™ SD1 Heavy metal	Reports the detection and estimation of the Heavy Metals
	MANNITAB™ SD1 Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	MANNITAB™ SD1 Nitrosamine	A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
	MANNITAB™ SD1 Allergen	Related to Regulation or specific allergens evaluated
	MANNITAB™ SD1 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™ SD1 Microanalytical	Report which shows Microbial limit test results
	MANNITAB™ SD1 Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	MANNITAB™ SD1 GRAS	GRAS: Generally Recognized as Safe
	MANNITAB™ SD1 Storage condition	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	MANNITAB™ SD1 Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	MANNITAB™ SD1 Genotoxic	Declaration if the material is free from Genotoxic Impurities
	MANNITAB™ SD1 Country of origin	It is the country of manufacture or production
	MANNITAB™ SD1 Aflatoxins	Declaration that the material is free from Aflatoxins
	MANNITAB™ SD1 Melamine	Declaration that confirm if the material is free of melamine contamination
	MANNITAB™ SD1 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™ SD1 Stability	To show that the stability meets the excipient specification
	MANNITAB™ SD1 Kosher	Certifies that this ingredient and the process of preparing it complies with orthodox kosher

MANNITAB™ SD1