Mannitol

USP-NF, Ph. Eur.

Description

Standard Mannitol powder

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 27 documents

Download selected

	Document name	Description	Download
	FARMAL® MN5000 EIP Index	Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
	FARMAL® MN5000 Specimen CoA	Certifies the quality of the excipient and demonstrates the batch meets the defined specification
	FARMAL® MN5000 Release Specification	Shows the quality standards of a material according to a list of tests required
	FARMAL® MN5000 MSDS	MSDS: Material Safety Data Sheet
	FARMAL® MN5000 Label	Displays the label graphic
	FARMAL® MN5000 TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	FARMAL® MN5000 Source of origin	The country of origin of the excipient
	FARMAL® MN5000 Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	FARMAL® MN5000 Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	FARMAL® MN5000 Heavy metal	Reports the detection and estimation of the Heavy Metals
	FARMAL® MN5000 Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	FARMAL® MN 5000 Nitrosamine	A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
	FARMAL® MN5000 Allergen	Related to Regulation or specific allergens evaluated
	FARMAL® MN5000 Gluten free	The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
	FARMAL® MN5000 Microanalytical	Report which shows Microbial limit test results
	FARMAL® MN5000 Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	FARMAL® MN5000 GRAS	GRAS: Generally Recognized as Safe
	FARMAL® MN5000 Storage conditions	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	FARMAL® MN5000 Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	FARMAL® MN5000 Genotoxic	Declaration if the material is free from Genotoxic Impurities
	FARMAL® MN 5000 Country of origin	It is the country of manufacture or production
	FARMAL® MN 5000 Aflatoxins	Declaration that the material is free from Aflatoxins
	FARMAL® MN5000 Melamine	Declaration that confirm if the material is free of melamine contamination
	FARMAL® MN5000 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.
	FARMAL® MN5000 Stability	To show that the stability meets the excipient specification
	FARMAL® MN5000 Halal	Halal indicates that this product is permitted and fit for consumption according to Islamic law
	FARMAL® MN5000 Kosher	Certifies that this ingredient and the process of preparing it complies with orthodox kosher