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Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) Grade Product Sheet

 

The Right DMSO for Drug Delivery Application

Vaccine vial and Syringe

Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) is the only grade of DMSO suitable for Healthcare and Drug Delivery applications. Gaylord Chemical’s USP grade is the only DMSO that is manufactured under cGMP conditions, in compliance with ICH Q7 guidelines for API, conforming to both the USP and Ph. Eur. Monographs.

Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) is supported by a Type II Drug Master File (DMF) with the FDA, a CEP granted by EDQM and a Type I DMF with Health Canada. It is the only DMSO product in the world with this level of regulatory support.

 

Versatile

  • As an Active Pharmaceutical Ingredient (API)
  • Excipient in Drug Delivery Systems to enhance efficacy of therapeutic agents
  • To solubilize active ingredients and polymers in drug delivery and Medical Devices
  • Depot Delivery as an API solvent
  • A Process aid in dosages and devices manufacture
  • Cryopreservation in cell culture, vaccines and drug delivery, also in storage of human umbilical cord blood, hemopoietic stem cells, and biological tissue.

Product Overview

Vaccine vial

  • An extremely polar solvent
  • Versatile pharmaceutical ingredient
  • Highly purified DMSO (min. 99.99%)
  • Odorless Clear Water-White liquid
  • Safe for use in most routes of administration

Extensive Regulatory Support

  • Procipient® is manufactured under cGMPs following ICH Q7 guidelines in a FDA regulated facility.
  • Multi-compendial, conforming to both the USP and Ph. Eur. Monographs.
  • Supported by a Type II DMF with the FDA, a Certificate of Suitability (CEP)
    granted by EDQM, and a Type I DMF with Health Canada
  • US FDA Generic Drug User Fee Amendments (GDUFA)
  • Supported by ICH Q1R(R2) Long-term stability data

Characteristics and Physical Properties

  • Completely water miscible
  • Chemically compatible with many organic and inorganic compounds
  • Outstanding solubility for an extensive range of Active Pharmaceutical Ingredients (API)
  • Broad compatibility with polymers, excipients and a list of API solubility
    measurements available
  • Low viscosity (2.0 cP @ 25°C)
  • Density similar to water (1.0955 g/mL @ 25°C)
  • Ability to depress freezing point of water
  • High Polarity of DMSO is responsible for its versatile solvent properties

 

Safety and Toxicity

  • Essentially non-toxic by all routes of administration
  • oral delivery (LD50 14,500-28,300 mg / kg, rat)
  • dermal delivery (LD50 40,000 mg / kg, rat)
  • SC injection (100% @ <0.5 mL; <15% @ 2.0 mL)
  • IV injectables should limit DMSO use to < 10%
  • Well characterized ADME profile
  • Not Carcinogenic, Mutagenic or a Reproductive Toxin (CMR)
  • Does not bioaccumulate

 

EXAMPLES OF APPROVED DOSAGE FORMS

Parenteral

  • Implantable medical device (106 mg)
  • Inter-arterial stroke rescue device
  • Long-acting SC/IM injectables (< 0.5 mL)
  • Bladder instillation (API, 50 mL)
  • Peptide Delivery System

Topical and Transdermal

  • Semisolid sports medicine OTC (15.5% w/w)
  • NSAID knee pain solution (45.5 % w/v1)
  • Sustained release patch transdermal drug delivery
  • Wound care dressing
  • Female Contraceptive Patch (18% w/w)

Biotech, Animal Health & Others

  • Human cord blood / stem cell cryopreservation
  • CAR T Therapy / leukemia or lymphoma
  • Equine topical solution (90% w/v)
  • Canine otic drug solution (60% w/v)
  • Lyophilization aid
  • Purification aid

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