D-Galactose, Plant Derived, LBLE-LEI

BIO EXCIPIENT GRADE / GA3251

INTENDED FOR USE AS AN EXCIPIENT

Product-image
formula-image

BIO EXCIPIENT GRADE / GA3251

CAS #: 59-23-4

Molecular Formula:

C6H12O6

Solubility in Water (g/L): 600

F.W.: 180.16 g/mol

pKa @ 20˚C: 12.4

COAs and Tech Docs

Low Bioburden, Low Endotoxin, Low Elemental Impurities


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.

NF Compendia 

ANALYSIS

SPECIFICATIONS
2Acidity  
Passes Test
2Appearance of Solution  

Passes Test
1Assay (HPLC)  
98.0 – 102.0%
2Identification A  
Conforms to Reference
1Identification B  
Passes Test
2Identification C  
Passes Test
2Microbial Content

Escherichia coli

Pseudomonas aeruginosa

Salmonella species

Staphylococcus aureus

TAMC

TYMC 

Absent

Absent

Absent

Absent

3≤ 50 CFU/g

≤ 50 CFU/g
1Related Substances

Glucose (HPLC)4

Lactose and 1,6-galactosyl-galactose

Galacturonic acid

Dextrose

Tagatose

Dulcitol

Arabinose

Any Unspecified Impurity

Total Impurities

≤ 0.1%

≤ 0.3%

≤ 0.2%

≤ 0.6%

≤ 0.2%

≤ 0.2%

≤ 0.3%

≤ 0.2%

≤ 0.8%
Residue on Ignition  

≤ 0.05%

Optical Rotation, Specific Rotation @ 20°C

 

 +78.0º to +81.5º
2Water  
≤ 1.0%

1Alternate Validated Method, 2Analyses are Harmonized, 3Specification is more stringent than Compendia Monograph
 * = Low Bioburden, Low Endotoxin product, ** = Low Elemental Impurities product


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 (HPLC)  
398.0 – 102.0%
2Identification A  
Conforms to Reference
1Identification B  
Passes Test
2Identification C  
Passes Test
2Microbial Content TAMC 
≤ 50 CFU/g
Proteins  
≤ 0.1 mg/mL
1Related Substances

Sum of Impurities A and B

Unspecified Impurities: for each impurity

Total Impurities

≤ 1.0%

≤ 0.2%

≤ 0.8%
Sulfated Ash  
≤ 0.1%
2Water  
≤ 1.0%


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


Additional Analyses

ANALYSIS

SPECIFICATIONS
Endotoxins  
≤ 1.0 EU/g

Trace Metals (USP <232> <233>)

Aluminum (Al)

Arsenic (As) (inorganic)

Barium (Ba) (NF)4

Cadmium (Cd)

Cobalt (Co)

Chromium (Cr)

Copper (Cu)

Iron (Fe)

Lead (PB) (NF)4

Manganese (Mn)

Mercury (Hg) (inorganic)

Molybdenum (Mo)

Nickel (Ni)

Selenium (Se)

Tungsten (W)

Vanadium (V)

Zinc (Zn)

≤ 63 ppb

≤ 50 ppb

≤ 63 ppb

≤ 10 ppb

≤ 50 ppb

≤ 50 ppb

≤ 25 ppb

≤ 200 ppb

≤ 50 ppb

≤ 25 ppb

≤ 50 ppb

≤ 50 ppb

≤ 50 ppb

≤ 50 ppb

≤ 50 ppb

≤ 50 ppb

≤ 200 ppb
1Residual Ethanol  
≤ 200 ppm3
1Residual Isopropanol  
≤ 500 ppm3
1Residual Methanol  
≤ 100 ppm3
1Residual Methyl Isobutyl Ketone  
≤ 500 ppm


1Alternate Validated Method, 2Analyses are Harmonized, 3Specification is more stringent than Compendia Monograph, 4NF Compendial Method 

Printable Version

Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
List of C of As files
No files available right now.

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

Please identify end use customer by full name and address
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

  • The Manufacturing of D-Galactose, Plant Derived GA3251 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 GA3251 manufactured at BioSpectra and its raw materials are allergen free.
  • BioSpectra certifies that all D-Galactose, Plant Derived GA3251 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 GA3251 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.

Expiration/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.