Sodium Starch Glycolate, Corn

USP-NF

Description

Lower cost superdisintegrant that promotes rapid disintegration and dissolution of solid dosage forms

Key benefits

Low concentration usage level
Long-term dissolution stability
This material is not compression and/or lubricant sensitive
EIP Index available

Functionalities

Superdisintegrant

Dosage form

Tablets
Hard Capsules

Files

Product documentation

This product has 27 documents

Download selected

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