FARMAL® SSG C

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 Tablets
  • Hard Capsules Hard Capsules
Files

Product documentation

This product has 27 documents

Document nameDescriptionDownload
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