D-Galactose, Plant Derived, LBLE-LEI
BIO EXCIPIENT GRADE / GA3251
INTENDED FOR USE AS AN EXCIPIENT
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
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.
- Spec Sheet
- Compliance
- C of As
- SDS
- Quick Inquiry
EP Compendia
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ANALYSIS |
SPECIFICATIONS |
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|---|---|---|---|
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Passes Test | ||
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White to almost white, crystalline powder | ||
|
Passes Test | ||
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97.0 – 102.0% | ||
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Passes Test | ||
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Passes Test | ||
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Passes Test | ||
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Passes Test | ||
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≤ 1.0% | ||
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≤ 0.5 ppm | ||
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≤ 100 CFU/g | ||
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≤ 0.1 mg/ml | ||
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≤ 0.1% | ||
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≤ 2.0% | ||
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≤ 0.3% each | ||
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≤ 1.0% |
NF Compendia
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ANALYSIS |
SPECIFICATIONS |
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|---|---|---|---|
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Passes Test | ||
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Passes Test | ||
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Passes Test | ||
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Passes Test | ||
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Passes Test | ||
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≤ 0.5 ppm | ||
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Absent Absent Absent Absent ≤ 1000 CFU/g ≤ 100 CFU/g |
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≤ 0.1% | ||
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+78.0 o to +81.5 o | ||
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≤ 1.0% | ||
|
ANALYSIS |
SPECIFICATIONS |
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≤ 2.5 EU/g | ||
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≤ 0.1% | ||
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≤ 400 ppb ≤ 10 ppb ≤ 50 ppb ≤ 50 ppb ≤ 25 ppb ≤ 200 ppb ≤ 25 ppb ≤ 50 ppb ≤ 50 ppb ≤ 50 ppb ≤ 50 ppb ≤ 200 ppb |
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≤ 500 ppm | ||
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≤ 5000 ppm | ||
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≤ 100 ppm | ||
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≤ 500 ppm |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH Q7 Compliant Manufactured | ||
|---|---|---|---|
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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Yes |
| List of C of As files |
|---|
| No files available right now. |
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.