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NEOSORB® PF Sorbitol - Pharma

NEOSORB® PF pyrogen-free sorbitol is used: as a carbohydrate source and osmotic diuretic agent in large-volume parenteral injectables as an isotonic agent for Rx injectables as an irrigating fluid for surgical procedures, to prevent intra- and extra-cellular dehydration

Brand: NEOSORB (5 products)

Chemical Name: D-Glucitol

Functions: Diuretic, Isotonic Agent

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), GMP, ISO 50001, ISO 9001, Kosher, United States Pharmacopeia (USP), cGMP

Labeling Claims: BSE-free, Non-GMO, Pyrogen-free, TSE-free, Vegan

Synonyms: D-Sorbitol, D-Sorbol, Diakarmon, G-ol, Glc-ol, Glucarine, Karion, Multitol, Sionit, Sionite, Sorbilande

Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Applications & Uses

Markets
Applications
Dosage Form
Uses

Neosorb PF is intended for use in preparing parenteral dosage forms.

Properties

Physical Form
Appearance
White or almost white crystalline powder, Clear, colorless in Solubility
Soluble in
Water
Insoluble in
Ethanol (96%)
Microbiological Values
ValueUnitsTest Method / Conditions
Bacterial endotoxinsmax. 2.5IU/gEP / NF
Escherichia coli (**)Not detectedper gramEP
Total Yeasts and Molds Countmax. 100%EP / NF
Total Aerobic Microbial Countmax. 100CFU/gEP / NF
Test Parameter
ValueUnitsTest Method / Conditions
pH Value3.5 - 7.0-NF
D-SORBITOL on DS97.0 - 102.0 / 91.0 - 100.5%EP / NF
Conductivitymax. 20microS/cmEP
Residue on Ignitionmax. 0.1%NF
Reducing Sugarsmax. 0.2 / max. 0.3%EP / NF
Impurity A: D-Mannitolmax. 2%EP
Impurity B: D-Iditolmax. 2%EP
Impurity C: D-Maltitolmax. 2%EP
Impurity between Maltitol & Mannitolmax. 1%
Any Unspecified Impuritymax. 0.10%
Amount of Related Substancesmax. 3%EP
Nickel Contentmax. 1mg/kgNF (**)
Water Contentmax. 1.5%EP / NF
Chloride Contentmax. 50mg/kgNF
Sulphate Contentmax. 100%NF
SalmonellaNot detected in 10gEP(**)
Note
  • "EP" stands for European Pharmacopeia
  • "NF" stands for National Formulary from USP-NF
  • (*) Compliance data - Tests not performed
  • (**) Monitoring plan

Regulatory & Compliance

Packaging & Availability

Packaging Information
  • Pack name: Strippable Paper Bag +Polyethylene Bag
  • Net weight: 25 kg
  • Pallet description: One Way Pallet 1200 X 1000 Perimeter Base HT
  • Units per pallet: 40 

Storage & Handling

Shelf Life
3 years
Storage
  • Manufacturing date + 3 years, in its unopened packaging.
  • We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations in temperature and humidity.
  • Upon opening, use the product as quickly as possible to prevent moisture regain.