D-Galactose, Milk Derived, LBLE

BIO EXCIPIENT GRADE | GM3250

INTENDED FOR USE AS AN EXCIPIENT

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formula-image

BIO EXCIPIENT GRADE | GM3250

CAS #: 59-23-4

Molecular Formula:

C6H12O6

Solubility in Water (g/L): 600

F.W.: 180.16 g/mol

pKa @ 25˚C: 12.4

COAs and Tech Docs

D-Galactose, Milk derived is intended for use upstream and downstream in biological drug manufacturing process. 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


Meets or exceeds EP/BP and NF specifications.

EP Compendia

ANALYSIS

SPECIFICATIONS
Acidity or Alkalinity  
Passes Test
Appearance  
White to almost white, crystalline powder
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
Impurities A and B  
≤ 1.0%
Lead  
≤ 0.5 ppm
Microbial Content TAMC
≤ 100 CFU/g
Proteins  
≤ 0.1 mg/ml
Sulfated Ash  
≤ 0.1%
Total Impurities  
≤ 2.0%
Unspecified Impurities  
≤ 0.3% each
Water  
≤ 1.0%

 

NF Compendia

ANALYSIS

SPECIFICATIONS
Acidity  
Passes Test
Appearance of Solution  
Passes Test
Barium  
Passes Test
Identification A  
Passes Test
Identification B  
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
Residue on Ignition  
≤ 0.1%
Optical Rotation, Specific Rotation  
+78.0 o to +81.5 o
Water  
≤ 1.0%

 

ANALYSIS

SPECIFICATIONS
Arsenic  
≤ 0.5 ppm
Endotoxins  
≤ 2.5 EU/g
Glucose  
≤ 0.1%
Iron  
≤ 5 ppm
Lead  
< 10 ppm
Melting Range  
162 - 179°C
Residual Ethanol  
≤ 500 ppm
Residual Isopropanol  
≤ 5000 ppm
Residual Methanol  
≤ 100 ppm
Residual Methyl Isobutyl Ketone  
≤ 500 ppm

 

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
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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, Milk Derived GM3250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment.
  • D-Galactose, Milk 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.
  • D-Galactose, Milk Derived at BioSpectra are not subject to genetic modification.
  • Synonyms: D-Galactopyranose


GMP Compliance:

Bio Excipient Grade D-Galactose, Milk Derived GM3250 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, Milk 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, Milk 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.