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

Files

Product documentation

This product has 27 documents

Download selected

	Document name	Description	Download
	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