Roquette offers reliable pyrogen-free products for life-saving injectables

Parenteral preparations are sterile preparations intended for administration by injection, infusion or implantation into the human or animal body.

Roquette offers a comprehensive range of outstandingly pyrogen-free pure materials for parenteral preparations:

LYCADEX® PF, pyrogen-free dextrose monohydrate

Dextrose monohydrate is mainly used as a carbohydrate source (energy nutrient) because it is rapidly and directly absorbed by the organism, without prior enzymatic breakdown. The function of dextrose as an isoosmotic isotonic agent is well established.

Main characteristics of our LYCADEX® PF dextrose monohydrate

  • White, crystalline, odourless, sweet tasting powder
  • CAS: 14431-43-7
  • EINECS: 200-075-1
  • Formula C6H12O6, H2O
  • Molecular weight 198.17 g/mol.
  • Compliant with EU and USP pharmacopoeias
  • A carefully controlled process for a high quality pyrogen-free grade
  • Freely soluble in water
  • Stable, relatively non-reactive and well characterized monosaccharide.

PEARLITOL® PF, pyrogen-free mannitol

PEARLITOL® PF mannitol used as an API

As an API, mannitol administered parenterally is generally used as:
  • an osmotic diuretic,
  • a diagnostic agent for kidney function,
  • an adjunct in the treatment of acute renal failure,
  • an agent to reduce intracranial pressure, treat cerebral oedema,
  • an agent to reduce intraocular pressure,
  • a detoxifier.

PEARLITOL® PF mannitol used as an excipient

Due to its exceptional physical and chemical properties (solubility and hygroscopicity), mannitol is the choice excipient for freeze-dried powder for injection or infusion.

  • Gives the freeze-dried material an aerated, light and porous structure.
  • Prevents from collapsing. 
  • Cryoprotective agent.

In some cases, mannitol has been used for its scavenging properties

In this case, it allows to avoid oxidative degradation of actives in implants.

NEOSORB® PF sorbitol

As an API, Sorbitol is used as an irrigating fluid for surgical procedures, to prevent intra- and extra-cellular dehydration. Sorbitol is also used as an active substance for its laxative effect. Although this application uses the oral route of administration, NEOSORB® PF sorbitol is recommended as it is an API in the Roquette range of products.

Main characteristics of our NEOSORB® PF sorbitolWhite crystalline powder

  • CAS: 50-70-4
  • EINECS: 200-061-5
  • Formula C6H14O6
  • Molecular weight 182.17 g/mol.
  • Compliant with current EU, USP and JP pharmacopoeias
  • High solubility
  • Good stability
  • Slightly hygroscopic

SODIUM GLUCONATE PHARMA

SODIUM GLUCONATE PHARMA is a highly purified grade for pharmaceutical applications:

  • As a physiological compatible electrolyte for pharmaceutical injectable preparations and for dialysis solutions
  • As a physiological compatible pH regulation agent

Main characteristics of our SODIUM GLUCONATE PHARMA

  • Crystalline, yellowish powder of sodium D-Gluconate
  • CAS: 527 – 07 – 1
  • EINECS: 208-407-7
  • Formula C6H11NaO7
  • Molecular weight 218.13 g/mol
  • Compliant with current USP pharmacopoeia.
  • Freely water soluble
  • Slightly hygroscopic

KLEPTOSE® HPB/HP, hydroxypropyl betacyclodextrin parenteral grade

KLEPTOSE® HPB and HP Hydroxypropyl betacyclodextrins are used in parenteral applications mainly for:

  • solubilizing drugs
  • stabilizing drugs against light or oxidation
  • reducing irritation at injection site

Main characteristics of our KLEPTOSE® HPB/HP

  • Hydroxypropyl betacyclodextrin (HPBCD) is a white, amorphous powder.
  • CAS: 128446-35-5
  • EINECS: 420-920-1
  • The HPBCD molecule is a torus shaped ring with a polar hydrophilic outside and an apolar hydrophobic cavity.
  • Two grades exist depending on the level of molar substitution (MS):
    • KLEPTOSE® HPB parenteral grade, medium MS (MS=0.65)
    • KLEPTOSE® HP parenteral grade, high MS (MS=0.85).
  • Average molecular weight is 1135 + 7*MS*58.1
  • Compliant with EP and USP monographs. In USA, a DMF type IV is available: n° 9420.
  • Infinitely soluble in water
  • High stability : very robust product that withstands acidic conditions and sterilization
  • Slightly hygroscopic

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