FARMAL® MGS

Magnesium Stearate

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

Description

Cost-effective lubricant for tableting manufacturing

Key benefits

  • Highly effective at low usage levels (i.e. 0.25% - 2.0%)
  • Hydrophobic material
  • Improves powder flow and reduces adhesion to punches and die cavities
  • EIP Index available

Functionalities

  • Lubricant

Dosage form

  • Tablets Tablets
Files

Product documentation

This product has 29 documents

Document nameDescriptionDownload
FARMAL® MGS EIP Index

Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand

FARMAL® MGS Specimen CoA IP

Certifies the quality of the excipient and demonstrates the batch meets the defined specification

FARMAL® MGS Specimen CoA

Certifies the quality of the excipient and demonstrates the batch meets the defined specification

FARMAL® MGS Release Specification

Shows the quality standards of a material according to a list of tests required

FARMAL® MGS Release Specification IP

Shows the quality standards of a material according to a list of tests required

FARMAL® MGS MSDS

MSDS: Material Safety Data Sheet

FARMAL® MGS Label

Displays the label graphic

FARMAL® MGS TSE BSE

TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)

FARMAL® MGS Source of origin

The country of origin of the excipient

FARMAL® MGS Regulatory Compliance

Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status

FARMAL® MGS Non-GMO

A declaration that the material is not derived from a Genetically Modified Organism (GMO)

FARMAL® MGS Heavy metal

Reports the detection and estimation of the Heavy Metals

FARMAL® MGS Elemental impurities

Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D

FARMAL® MGS Nitrosamine

A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material

FARMAL® MGS Allergen

Related to Regulation or specific allergens evaluated

FARMAL® MGS 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® MGS Microanalytical

Report which shows Microbial limit test results

FARMAL® MGS Residual solvent

Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia

FARMAL® MGS GRAS

GRAS: Generally Recognized as Safe

FARMAL® MGS Storage condition

The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies

FARMAL® MGS Latex free

Certifies that the material is not made with natural rubber latex, latex derivatives

FARMAL® MGS Genotoxic

Declaration if the material is free from Genotoxic Impurities

FARMAL® MGS Viral microbiological

Viral safety information

FARMAL® MGS Melamine

Declaration that confirm if the material is free of melamine contamination

FARMAL® MGS 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® MGS Stability

To show that the stability meets the excipient specification

FARMAL® MGS Stability IP

To show that the stability meets the excipient specification

FARMAL® MGS Kosher

Certifies that this ingredient and the process of preparing it complies with orthodox kosher

FARMAL® MGS Halal

Halal indicates that this product is permitted and fit for consumption according to Islamic law