ICH-Q7 GMP Manufactured Product
*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
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ANALYSIS |
SPECIFICATIONS (EP) |
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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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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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≤ 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
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.
The recommended retest period for D-Galactose, Plant Derived is two years from the date of manufacture.
Ship and store in ambient temperature. Keep container tightly closed in a dry and well-ventilated place.
10kg & 25kg pails.
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.