MANNITAB™ F2

Mannitol

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

Description

Mannitol powder, average mean particle size 50 μ approx.

MANNITAB is a trademark of the Ingredion and MB Sugars Joint Venture

Key benefits

  • High solubility in water enhances dissolution
  • Non-hygroscopic
  • Physically and chemically stable (non-reactive)
  • EIP Index available

Functionalities

  • Filler

Dosage form

  • Tablets Tablets
Files

Product documentation

This product has 26 documents

Document nameDescriptionDownload
MANNITAB™ F2 EIP Index

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

MANNITAB™ F2 Export Specimen CoA

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

MANNITAB™ F2 Domestic Specimen CoA

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

MANNITAB™ F2 Release Specification

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

MANNITAB™ F2 MSDS

MSDS: Material Safety Data Sheet

MANNITAB™ F2 TSE BSE

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

MANNITAB™ F2 Source of origin

The country of origin of the excipient

MANNITAB™ F2 Regulatory Compliance

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

MANNITAB™ F2 Non-GMO

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

MANNITAB™ F2 Heavy metal

Reports the detection and estimation of the Heavy Metals

MANNITAB™ F2 Elemental impurities

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

MANNITAB™ F2 Nitrosamine

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

MANNITAB™ F2 Allergen

Related to Regulation or specific allergens evaluated

MANNITAB™ F2 Gluten free

The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)

MANNITAB™ F2 Microanalytical

Report which shows Microbial limit test results

MANNITAB™ F2 Residual solvent

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

MANNITAB™ F2 GRAS

GRAS: Generally Recognized as Safe

MANNITAB™ F2 Storage condition

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

MANNITAB™ F2 Latex free

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

MANNITAB™ F2 Genotoxic

Declaration if the material is free from Genotoxic Impurities

MANNITAB™ F2 Viral microbiological

Viral safety information

MANNITAB™ F2 Melamine

Declaration that confirm if the material is free of melamine contamination

MANNITAB™ F2 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.

MANNITAB™ F2 Stability

To show that the stability meets the excipient specification

MANNITAB™ F2 Halal

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

MANNITAB™ F2 Kosher

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