FARMAL® MN 5000

Mannitol

USP-NF, Ph. Eur., Ch.P, IP

Description

Standard Mannitol powder

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 25 documents

Document nameDescriptionDownload
FARMAL® MN5000 EIP Index

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

FARMAL® MN5000 Specimen CoA

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

FARMAL® MN5000 Release Specification

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

FARMAL® MN5000 MSDS

MSDS: Material Safety Data Sheet

FARMAL® MN5000 Label

Displays the label graphic

FARMAL® MN5000 TSE BSE

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

FARMAL® MN5000 Source of origin

The country of origin of the excipient

FARMAL® MN5000 Regulatory Compliance

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

FARMAL® MN5000 Non-GMO

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

FARMAL® MN5000 Heavy metal

Reports the detection and estimation of the Heavy Metals

FARMAL® MN5000 Elemental impurities

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

FARMAL® MN5000 Allergen

Related to Regulation or specific allergens evaluated

FARMAL® MN5000 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® MN5000 Microanalytical

Report which shows Microbial limit test results

FARMAL® MN5000 Residual solvent

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

FARMAL® MN5000 GRAS

GRAS: Generally Recognized as Safe

FARMAL® MN5000 Storage conditions

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

FARMAL® MN5000 Latex free

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

FARMAL® MN5000 Genotoxic

Declaration if the material is free from Genotoxic Impurities

FARMAL® MN5000 Viral microbiological

Viral safety information

FARMAL® MN5000 Melamine

Declaration that confirm if the material is free of melamine contamination

FARMAL® MN5000 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® MN5000 Stability

To show that the stability meets the excipient specification

FARMAL® MN5000 Halal

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

FARMAL® MN5000 Kosher

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