Sorbitol Sorbitan

USP-NF

Description

Plasticizer for the softgel capsule shell with strict microbiological controls

Key benefits

Long-lasting plasticization with a smooth and elegant finish
Mechanically stable shell that eases handling and inhibits blooming
Reduced drying times lead to productivity and savings

Functionalities

Plasticizer

Dosage form

Softgel Capsule

Files

Product documentation

This product has 22 documents

Download selected

	Document name	Description	Download
	FARMAL® SS 2515 R EIP Index	Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
	FARMAL® SS 2515 R Release Specification	Shows the quality standards of a material according to a list of tests required
	FARMAL® SS 2515 R TSE BSE	TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
	FARMAL® SS 2515 R Source of origin	The country of origin of the excipient
	FARMAL® SS 2515 R Regulatory Compliance	Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
	FARMAL® SS 2515 R Non-GMO	A declaration that the material is not derived from a Genetically Modified Organism (GMO)
	FARMAL® SS 2515 R Heavy metal	Reports the detection and estimation of the Heavy Metals
	FARMAL® SS 2515 R Elemental impurities	Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
	FARMAL® SS 2515 R Nitrosamine	A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
	FARMAL® SS 2515 R Allergen	Related to Regulation or specific allergens evaluated
	FARMAL® SS 2515 R 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® SS 2515 R Microanalytical	Report which shows Microbial limit test results
	FARMAL® SS 2515 R Residual solvent	Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
	FARMAL® SS 2515 R GRAS	GRAS: Generally Recognized as Safe
	FARMAL® SS 2515 R Storage condition	The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
	FARMAL® SS 2515 R Latex free	Certifies that the material is not made with natural rubber latex, latex derivatives
	FARMAL® SS 2515 R Genotoxic	Declaration if the material is free from Genotoxic Impurities
	FARMAL® SS 2515 R Country of origin	It is the country of manufacture or production
	FARMAL® SS 2515 R Aflatoxins	Declaration that the material is free from Aflatoxins
	FARMAL® SS 2515 R Melamine	Declaration that confirm if the material is free of melamine contamination
	FARMAL® SS 2515 R Halal	Halal indicates that this product is permitted and fit for consumption according to Islamic law
	FARMAL® SS 2515 R Kosher Declaration	Certifies that this ingredient and the process of preparing it complies with orthodox kosher