Mannitol

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

Description

Mannitol powder, average mean particle size 25 μ approx.

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

Key benefits

High solubility in water enhances dissolution
Non-hygroscopic
Physically and chemically stable (non-reactive)
EIP Index available

Functionalities

Filler

Dosage form

Tablets

EIP Documentation updated in Dec. 24

Product documentation

This product has 29 documents

Download selected

	Document name	Description	Download
	MANNITAB™ F1 EIP Index	Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
	MANNITAB™ F1 Export Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	MANNITAB™ F1 Domestic Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	MANNITAB™ F1 Export Release Specification	Shows the quality standards of a material according to a list of tests required
	MANNITAB™ F1 Domestic Release Specification	Shows the quality standards of a material according to a list of tests required
	MANNITAB™ F1 MSDS	MSDS: Material Safety Data Sheet
	MANNITAB™ F1 Export Specimen Label	Displays the label graphic
	MANNITAB™ F1 Domestic Specimen Label	Displays the label graphic
	MANNITAB™ F1 TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	MANNITAB™ F1 Source of origin	The country of origin of the excipient
	MANNITAB™ F1 Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	MANNITAB™ F1 Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	MANNITAB™ F1 Heavy metal	Reports the detection and estimation of the Heavy Metals
	MANNITAB™ F1 Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	MANNITAB™ F1 Nitrosamine	A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
	MANNITAB™ F1 Allergen	Related to Regulation or specific allergens evaluated
	MANNITAB™ F1 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™ F1 Microanalytical	Report which shows Microbial limit test results
	MANNITAB™ F1 Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	MANNITAB™ F1 GRAS	GRAS: Generally Recognized as Safe
	MANNITAB™ F1 Storage condition	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	MANNITAB™ F1 Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	MANNITAB™ F1 Genotoxic	Declaration if the material is free from Genotoxic Impurities
	MANNITAB™ F1 Country of origin	It is the country of manufacture or production
	MANNITAB™ F1 Aflatoxins	Declaration that the material is free from Aflatoxins
	MANNITAB™ F1 Melamine	Declaration that confirm if the material is free of melamine contamination
	MANNITAB™ F1 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™ F1 Stability	To show that the stability meets the excipient specification
	MANNITAB™ F1 Kosher	Certifies that this ingredient and the process of preparing it complies with orthodox kosher

MANNITAB™ F1