Croscarmellose Sodium

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

Description

Premium high performance superdisintegrant that promotes rapid disintegration and dissolution of solid dosage forms

Key benefits

High performance with a low concentration usage level
Excellent long-term dissolution stability
EIP Index available

Functionalities

Superdisintegrant

Dosage form

Tablets
Hard Capsules

EIP Documentation updated in Dec. 24

Product documentation

This product has 30 documents

Download selected

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

FARMAL® CCS