ICH-Q7 GMP Manufactured Product
Galactose(D)
*Low Bioburden, Low Endotoxin
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.
CAS #: 59-23-4
Formula: C6H12O6
Sol. In H2O (g/L): 600
F.W.: 180.16 g/mol
pKa @ 25˚C: 12.4
Product Specifications:
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ANALYSIS |
SPECIFICATIONS (EP) |
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|---|---|---|---|
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Passes Test | ||
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White to almost white, crystalline powder | ||
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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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≤ 100 CFU/g | ||
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≤ 0.1 mg/ml | ||
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≤ 1.0% |
||
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≤ 0.1% | ||
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≤ 1.0% |
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ANALYSIS |
SPECIFICATIONS (NF) |
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|---|---|---|---|
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Passes Test | ||
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Passes Test | ||
| Assay | 98.0% - 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 | ||
| Limit of Lead | ≤ 0.5 ppm | ||
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Absent Absent Absent Absent ≤ 1000 CFU/g ≤ 100 CFU/g |
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≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.2% ≤ 1.0% |
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≤ 0.1% | ||
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+78.0o to +81.5o | ||
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≤ 1.0% |
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ANALYSIS (ADDITIONAL) |
SPECIFICATIONS |
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|---|---|---|---|
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≤ 2.5 EU/g | ||
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≤ 0.1% | ||
| Lead | ≤ 0.5 ppm | ||
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≤ 500 ppm | ||
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≤ 5000 ppm | ||
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≤ 100 ppm | ||
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≤ 500 ppm |
Printable Version
General Product Description:
- The Manufacturing of D-Galactose, Plant Derived GALP-3250 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
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all D-Galactose, Plant Derived GALP-3250 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-3250 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.
Retest Date:
The recommended retest period for D-Galactose, Plant 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.
Bulk GMP Fine Chemicals exclusively manufactured in North America
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.