UNI-PURE® WG 220 (China)

Fully Pregel starch, corn

USP-NF, Ch. P.

Description

Multi-compendial binder for your wet granulation formulations

Key benefits

  • Improves granulation flow and compressibility
  • Simplifies process and reduces cost
  • Dry blend binder, eliminates solution preparation
  • Multi-sourcing: China and India
  • EIP Index available

Functionalities

  • Binder

Dosage form

  • Tablets Tablets
Files

Product documentation

This product has 27 documents

Document nameDescriptionDownload
UNI-PURE® WG220 (China) EIP Index

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

UNI-PURE® WG220 (China) Specimen CoA

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

UNI-PURE® WG220 (China) Release Specification

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

UNI-PURE® WG220 (China) MSDS in Chinese

MSDS: Material Safety Data Sheet

UNI-PURE® WG220 (China) MSDS

MSDS: Material Safety Data Sheet

UNI-PURE® WG220 (China) Label

Displays the label graphic

UNI-PURE® WG220 (China) TSE BSE

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

UNI-PURE® WG220 (China) Source of origin

The country of origin of the excipient

UNI-PURE® WG220 (China) Regulatory Compliance

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

UNI-PURE® WG220 (China) Non-GMO

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

UNI-PURE® WG220 (China) Heavy metal

Reports the detection and estimation of the Heavy Metals

UNI-PURE® WG220 (China) Elemental impurities

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

UNI-PURE® WG220 (China) Nitrosamine

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

UNI-PURE® WG220 (China) Allergen

Related to Regulation or specific allergens evaluated

UNI-PURE® WG220 (China) Gluten free

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

UNI-PURE® WG220 (China) Microanalytical

Report which shows Microbial limit test results

UNI-PURE® WG220 (China) Microanalytical

Report which shows Microbial limit test results

UNI-PURE® WG220 (China) Residual solvent

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

UNI-PURE® WG220 (China) GRAS

GRAS: Generally Recognized as Safe

UNI-PURE® WG220 (China) Storage condition

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

UNI-PURE® WG220 (China) Latex free

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

UNI-PURE® WG220 (China) Genotoxic free

Declaration if the material is free from Genotoxic Impurities

UNI-PURE® WG220 (China) Melamine

Declaration that confirm if the material is free of melamine contamination

UNI-PURE® WG220 (China) 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.

UNI-PURE® WG220 (China) Stability

To show that the stability meets the excipient specification

UNI-PURE® WG220 (China) Kosher

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

UNI-PURE® WG220 (China) Halal

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