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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 (8 products)

Chemical Name: D-Glucitol

CAS Number: 50-70-4

Dosage Form: Injectables

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

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

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

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
D-Glucitol
Pharma & Nutraceuticals Functions
Diuretic,
Isotonic Agent,
Osmotic Agent
CAS No.
50-70-4
EC No.
200-061-5
Technologies
Pharmaceuticals & Nutraceuticals,
Ready-to-Use Products
Product Families
Ready-to-Use Products — Cleaners
Medical Grade Cleaners
Pharmaceuticals & Nutraceuticals — Excipients
Formulation & Processing Aids
Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors
Active Pharmaceutical Ingredients (APIs)

Features & Benefits

Benefit Claims
Good Consistency,
High Purity
Labeling Claims
BSE-free,
Kosher,
Non-GMO,
Pyrogen-free,
TSE-free,
Vegan

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Parenteral
Application Area
Medical Applications
Dosage Form
Injectables
Uses

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

Properties

Physical Form
Powder
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

Certifications & Compliance
European Pharmacopeia (Ph. Eur.),
GMP,
ISO 50001,
ISO 9001,
Kosher,
United States Pharmacopeia (USP),
cGMP
Chemical Inventories
AICS (Australia),
DSL (Canada),
EINECS (EU),
ENCS (Japan),
IECSC (China),
INSQ (Mexico),
KECI (Korea),
NCI (Vietnam),
NZIoC (New Zealand),
PICCS (Phillipines),
TCSI (Taiwan),
TSCA (USA)
Grade
Pharma Grade

Packaging & Availability

Packaging Type
Bags
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.