Product Category

Excipient

ICH-Q7 GMP Manufactured Product

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

Low Bioburden, Low Endotoxin, Low Elemental Impurities, EP, BP, NF, GMP Manufactured, Excipient Grade Product

Product Code: GALP-3251 | Previously: GA3251

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

NF COMPENDIA

ANALYSIS

SPECIFICATIONS

2Acidity  
Passes Test
2Appearance of Solution  

Passes Test

1Assay  
98.0% – 102.0%

Barium

Passes Test

2Identification A  
Conforms to Reference
1Identification B  
Passes Test
2Identification C  
Passes Test

1Limit of Lead

≤ 0.5 ppm

2Microbial Content

Escherichia coli

Pseudomonas aeruginosa

Salmonella species

Staphylococcus aureus

TAMC

TYMC

Absent

Absent

Absent

Absent

3≤ 100 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 @ 20°C

 

 +78.0º to +81.5º

2Water  
≤ 1.0%

 

EP COMPENDIA

ANALYSIS

SPECIFICATIONS

2Acidity or Alkalinity  
Passes Test
Appearance  

White to almost white, crystalline or finely granulated powder

2Appearance of Solution  
Passes Test
1Assay  
398.0 – 102.0%
2Identification A  
Conforms to Reference
1Identification B  
Passes Test
2Identification C  
Passes Test
2Microbial Content TAMC 
≤ 100 CFU/g
Proteins  
≤ 0.1 mg/mL
1Related Substances

Sum of Impurities A and B

Unspecified Impurities: for each impurity

Total Impurities

≤ 1.0%

≤ 0.3%

≤ 2.0%

Sulfated Ash  
≤ 0.1%
2Water  
≤ 1.0%

 

ADDITIONAL ANALYSES

ANALYSIS

SPECIFICATIONS

Endotoxins  
≤ 2.5 EU/g

1Glucose

 

≤ 0.1%

Trace Metals

Aluminum (Al)

Cadmium (Cd)

Cobalt (Co)

Chromium (Cr)

Copper (Cu)

Iron (Fe)

Manganese (Mn)

Molybdenum (Mo)

Nickel (Ni)

Selenium (Se)

Vanadium (V)

Zinc (Zn)

≤ 400 ppb

≤ 10 ppb

≤ 50 ppb

≤ 50 ppb

≤ 25 ppb

≤ 200 ppb

≤ 25 ppb

≤ 50 ppb

≤ 50 ppb

≤ 50 ppb

≤ 50 ppb

≤ 200 ppb

1Residual Ethanol  
≤ 500 ppm
1Residual Isopropanol  
≤ 5000 ppm
1Residual Methanol  
≤ 100 ppm
1Residual Methyl Isobutyl Ketone  
≤ 500 ppm


1
Alternate Validated Method
2Analyses are Harmonized
3Specification is more stringent than Compendia Monograph

Printable Version

Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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COAs and Tech Docs

Product-image
formula-image

GALP-3251

CAS #: 59-23-4

Formula: C6H12O6

Sol. In H2O (g/L): 600

F.W.: 180.16 g/mol

pKa @ 20˚C: 12.4

General Product Description:

  • The Manufacturing of D-Galactose, Plant Derived GALP-3251 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-3251 manufactured at BioSpectra and its raw materials are allergen free.
  • BioSpectra certifies that all D-Galactose, Plant Derived GALP-3251 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-3251 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of D-Galactose, Plant Derived is not suitable to be used as an 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.

Additional Packaging Information

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