ICH-Q7 GMP Manufactured Product
*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.
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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NF COMPENDIA |
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ANALYSIS |
SPECIFICATIONS |
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Passes Test | ||
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Passes Test |
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98.0% – 102.0% | ||
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Barium |
Passes Test |
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Conforms to Reference | ||
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Passes Test | ||
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Passes Test | ||
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1Limit of Lead |
≤ 0.5 ppm |
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Absent Absent Absent Absent 3≤ 100 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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EP COMPENDIA |
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ANALYSIS |
SPECIFICATIONS |
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Passes Test | ||
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White to almost white, crystalline or finely granulated powder |
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Passes Test | ||
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398.0 – 102.0% | ||
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Conforms to Reference | ||
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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% ≤ 0.3%
≤ 2.0% |
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≤ 0.1% | ||
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≤ 1.0% | ||
| ADDITIONAL ANALYSES | |||
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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 | ||
Printable Version
Bio Excipient Grade D-Galactose, Plant Derived GALP-3251 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of D-Galactose, Plant Derived is not suitable to be used as an 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.
Keep container tightly closed and store in a clean, dry and well-ventilated area. Store in the original container.
10kg & 25kg pails and 50kg drum.
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.