Product Category

Excipient

ICH-Q7 GMP Manufactured Product

D-GALACTOSE
LBLE, EP, NF, GMP, Plant Derived

Low Bioburden, Low Endotoxin, EP, NF, GMP Manufactured,
Excipient Grade Product

Product Code: GALP-3250 | Previously: GA3250

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.

Product Specifications

ANALYSIS

SPECIFICATIONS (EP)

Acidity or Alkalinity  
Passes Test
Appearance  
White to almost white, crystalline powder
Appearance of Solution  
Passes Test
Assay  
97.0% – 102.0%
Barium  
Passes Test
Identification A  
Passes Test
Identification B  
Passes Test
Identification C  
Passes Test
Microbial Content TAMC 
≤ 100 CFU/g
Proteins  
≤ 0.1 mg/ml
Related Substances Impurities A and B
Unspecified Impurities
Total Impurities 

≤ 1.0%
≤ 0.3% each
≤ 2.0%

Sulfated Ash  
≤ 0.1%
Water  
≤ 1.0%

 

ANALYSIS

SPECIFICATIONS (NF)

Acidity  
Passes Test
Appearance of Solution  
Passes Test
Assay 98.0% - 102.0%
Barium  
Passes Test
Identification A  
Passes Test
Identification B  
Passes Test
Identification C  
Passes Test
Limit of Lead ≤ 0.5 ppm
Microbial Content

Escherichia coli

Pseudomonas aeruginosa

Salmonella species

Staphylococcus aureus

TAMC

TYMC

Absent

Absent

Absent

Absent

≤ 1000 CFU/g

≤ 100 CFU/g

1Related Substances

Lactose and 1, 6-galactosyl-galactose

Galacturonic acid

Dextrose

Tagatose

Dulcitol

Arabinose

Any Unspecified Impurity

Total Impurities

≤ 0.6%

≤ 0.6%

≤ 0.6%

≤ 0.6%

≤ 0.6%

≤ 0.6%

≤ 0.2%

≤ 1.0% 
Residue on Ignition  
≤ 0.1%
Optical Rotation, Specific Rotation  
+78.0o to +81.5o
Water  
≤ 1.0%

 

ANALYSIS (ADDITIONAL)

SPECIFICATIONS

Endotoxins  
≤ 2.5 EU/g
Glucose  
≤ 0.1%
Lead ≤ 0.5 ppm
Residual Ethanol  
≤ 500 ppm
Residual Isopropanol  
≤ 5000 ppm
Residual Methanol  
≤ 100 ppm
Residual Methyl Isobutyl Ketone  
≤ 500 ppm

 

Printable Version

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General Product Description:

  • The Manufacturing of D-Galactose, Plant Derived GALP-3250 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
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all D-Galactose, Plant Derived GALP-3250 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-3250 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:

Ship and store in ambient temperature. Keep container tightly closed in a dry and well-ventilated place.

Package Sizes:

10kg & 25kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging