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Excipient, ICH-Q7 GMP Manufactured Product 
Galactose(D), Plant Derived, EP, NF, LBLE*, Ultra Low LEI**, GMP Grade
 *Low Bioburden, Low Endotoxin, **Low Elemental Impurities

Product Code: GALP-3351

CAS #: 59-23-4
Formula: C6H12O6
Sol. In H2O (g/L): 600
F.W.: 180.16 g/mol
pKa @ 25˚C: 12.4 

Minimum Order Quantity: 25kg | Lead Time: If Stock, 1-month/ No Stock, 6-months | Package Sizes: 10kg & 25kg pails and 50kg drum. 

Specifications
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Intended for Use in Pharma Mfg. Requiring ICH-Q7, Excipient Grade Quality & Regulatory Compliance

  • D-Galactose, Plant Derived is intended for use upstream and downstream in biological drug manufacturing processes. For this purpose, BioSpectra has categorized our product as an excipient though one of the primary functions is to be used as a nutrient in mammalian cell culture media. Given the sensitivity of these cells in regard to growth, BioSpectra’s D-Galactose is manufactured to meet high purity specifications and low bioburden and endotoxin demands. 

General Product Description:

  • The Manufacturing of D-Galactose, Plant Derived GALP-3351 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment.
    D-Galactose, Plant Derived is a white to almost white crystalline powder
  • Molecular Formula: C6H12O6
  • Molecular Weight: 180.16 g/mol
  • CAS Number: 59-23-4
  • BioSpectra certifies that all D-Galactose, Plant Derived GALP-3351 manufactured at BioSpectra and its raw materials are allergen free.
  • BioSpectra certifies that all D-Galactose, Plant Derived GALP-3351 manufactured
    at BioSpectra, and its raw materials, are not derived from or come in contact with animal parts, products, and/or byproducts.
  • D-Galactose, Plant Derived manufactured at BioSpectra and any raw materials used in the manufacture of D-Galactose, Plant Derived at BioSpectra are not subject to genetic modification.
  • Synonyms: D-Galactopyranose

GMP Compliance:

  • Bio Excipient Grade D-Galactose, Plant Derived GALP-3350 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH-Q7 Compliant cGMP Manufactured non-Sterile Excipient for use in further Manufacturing. This Grade of D-Galactose, Plant Derived is not suitable to be used as a Sterile or Injectable Excipient, Active Pharmaceutical Ingredient, Drug Product or Household Item. 

Retest Date:

  • The recommended retest period for D-Galactose, Plant Derived is two years from the date of manufacture.

Storage and Shipping Conditions:

  • Keep container tightly closed and store in a clean, dry and well-ventilated area. Store in the original container. 

Package Sizes:

  • 10kg & 25kg pails and 50kg drum.