Magnesium Stearate

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

Description

Cost-effective lubricant for tableting manufacturing

Key benefits

Highly effective at low usage levels (i.e. 0.25% - 2.0%)
Hydrophobic material
Improves powder flow and reduces adhesion to punches and die cavities
EIP Index available

Functionalities

Lubricant

Dosage form

Tablets

EIP Documentation updated in Dec. 24

Product documentation

This product has 30 documents

Download selected

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