LYCADEX® PF Dextrose Monohydrate Pyrogen Free

1 of 4 products in this brand
LYCADEX® PF is a pyrogen-free dextrose monohydrate that can be used: as isotonic agent in Rx excipients and in injectable applications including large volume parenteral, total parenteral nutrition as a carbohydrate source and osmotic agent for hemodialysis and peritoneal dialysis

Chemical Name: Dextrose Monohydrate, α-D-Glucose monohydrate

Functions: Isotonic Agent, Osmotic Agent

Certifications & Compliance: DMF Type II, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Halal, ISO 9001, Indian Pharmacopeia, Kosher, United States Pharmacopeia (USP)

Labeling Claims: BSE-free, Halal, Kosher, Melamine-free, Non-Hazardous, Pyrogen-free, TSE-free, Vegan

Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions

Features & Benefits

Benefit Claims

Applications & Uses

Dosage Form


Physical Form
White or almost white crystalline powder, Complies in Solution
Soluble in
Slightly Soluble In
Typical Properties
ValueUnitsTest Method / Conditions
Identification Test-ACompliesEP
Identification Test-A (*)CompliesUSP
Identification Test-BCompliesEP / USP
Identification Test-CCompliesUSP
Identification Test-ECompliesEP
Identification Test-1 (*)CompliesJP
Identification Test-2CompliesJP
Conductivitymax. 20microS/cmEP / USP / JP
DextrinCompliesEP / USP / JP
Soluble Starch Sulfites (**)max. 15EP / USP / JP
Water Content7.5 - 9.5%EP / USP / JP
Heavy Metals (*)max. 4mg/kgJP
Assay (on DS)97.5 - 102.0%EP / USP / JP
Sum of Impurities A and B (Impurity A:Maltose - Impurity B:Isomaltose)max. 0.4%EP - USP - JP
Impurities C: Maltotriosemax. 0.2%EP - USP - JP
Impurities D: Fructosemax. 0.15%EP - USP - JP
Unspecified Impuritiesmax. 0.10%EP - USP - JP
Total Impuritiesmax. 0.5%EP - USP - JP
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 100CFU/g
Bacterial endotoxinsmax. 1.25EU/GLAL TEST
Total Yeasts and Moulds Countmax. 100CFU/g
Escherichia coli (**)Not detectedper gram
Salmonella (**)Not detectedper 10g
Pyrogen Test (**)


  • Solute at 150 g/L
  • Sterilized 10 mn at 110 D.C
  • Injection 10 mL/Kg
  • "EP" - stands for European Pharmacopeia
  • "USP" - stands for USP Pharmacopeia
  • "JP" - stands for JP Pharmacopeia
  • (*) - Compliance data - Tests not performed
  • (**) - Monitoring plan

Regulatory & Compliance


Conforms to the requirements of the current monograph

  • European Pharmacopeia (EP) GLUCOSE MONOHYDRATE (0178)
  • US Pharmacopeia (USP) DEXTROSE
  • Japanese Pharmacopeia (JP) Glucose Hydrate

Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).

Technical Details & Test Data

Test Data
  • Intended for use in manufacture of parenteral dosage forms.
  • Methods used by Roquette may be the Pharmacopeia methods or alternative validated methods which have been compared to the Pharmacopeia methods.

Packaging & Availability

Packaging Information
  • ROQ Product Code: 493404
  • Article (SKU) Code: 493404107E
  • Package Size & Type: 15 kg PE lined cardboard box

Storage & Handling


Retest Date Manufacturing date + 2 years, in its unopened packaging.

  • We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity.
  • Upon opening, use the product as quickly as possible to prevent moisture regain.