D-Galactose, Milk Derived, LBLE
BIO EXCIPIENT GRADE | GM3250
INTENDED FOR USE AS AN EXCIPIENT
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
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.
- Spec Sheet
- Compliance
- C of As
- SDS
- Quick Inquiry
EP/NF Compendia
|
ANALYSIS |
SPECIFICATIONS |
||
|---|---|---|---|
|
Passes Test | ||
|
White to almost white, crystalline powder | ||
|
Passes Test | ||
|
98.0 – 102.0% | ||
|
Passes Test | ||
|
Passes Test | ||
|
Passes Test | ||
|
Passes Test | ||
|
≤ 1.0% | ||
|
≤ 0.5 ppm | ||
|
≤ 100 CFU/g | ||
|
≤ 0.1 mg/ml | ||
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≤ 0.1% | ||
|
≤ 2.0% | ||
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≤ 0.3% each | ||
|
≤ 1.0% | ||
|
ANALYSIS |
SPECIFICATIONS |
||
|
Passes Test | ||
|
Passes Test | ||
|
Passes Test | ||
|
Passes Test | ||
|
Passes Test | ||
|
≤ 0.5 ppm | ||
|
Absent Absent Absent Absent ≤ 1000 CFU/g ≤ 100 CFU/g |
||
|
≤ 0.1% | ||
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+78.0o to +81.5o | ||
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≤ 1.0% | ||
|
ANALYSIS |
SPECIFICATIONS |
||
|
≤ 0.5 ppm | ||
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≤ 2.5 EU/g | ||
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≤ 0.1% | ||
|
≤ 5 ppm | ||
|
< 10 ppm | ||
|
162 - 179°C | ||
|
≤ 500 ppm | ||
|
≤ 5000 ppm | ||
|
≤ 100 ppm | ||
|
≤ 500 ppm |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH Q7 Compliant Manufactured | ||
|---|---|---|---|
|
Yes | ||
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Yes | ||
|
Yes | ||
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Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
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Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
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Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Yes | ||
|
Yes | ||
|
Yes |
| List of C of As files |
|---|
| No files available right now. |
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:
Package Sizes:
10kg & 25kg pails.
Ship and store in ambient temperature. Keep container tightly closed in a dry and well-ventilated place.