Sodium Stearyl Fumarate

USP-NF, Ph. Eur.

Description

Our FARMAL SSF, Sodium Stearyl Fumarate, is a high-performance lubricant for tableting manufacturing.

It provides excellent lubrication, reducing friction during the tablet manufacturing process, preventing material to stick to the equipment besides improving tablet hardness, uniformity and disintegration time.

For more information, please contact your key account manager or email us

Key benefits

Highly effective at low usage levels (i.e. 0.25% - 3.0%)
Particularly well suited for effervescent and fast dissolving tablets
EIP Index available

Functionalities

Lubricant

Dosage form

Tablets

EIP Documentation updated in Feb. 25

Product documentation

This product has 28 documents

Download selected

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

FARMAL® SSF