GMP Biotech Product
GALACTOSE (D) BIOTECH
PLANT DERIVED, EP, NF, LBLE*, GMP
*Low Bioburden, Low Endotoxin
COAs Spec Sheet
Product Code: GALP-4250
Intended for Use in Biopharmaceutical & Biotechnological Applications and Products
D-Galactose, plant derived, is intended for use upstream and downstream in biopharmaceutical and biotech manufacturing processes and products. BioSpectra’s D-Galactose is manufactured to meet high purity specifications and low bioburden and endotoxin demands. This product is manufactured under full GMP conditions and meets multicompendial specifications.
Formula: C6H12O6
F.W.: 180.16 g/mol
CAS #: 59-23-4
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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Passes Test | ||
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Passes Test | ||
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98.0% - 102.0% | ||
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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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≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.2% ≤ 1.0% |
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≤ 0.1% | ||
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+78.0° to +81.5° | ||
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≤ 2.5 EU/g | ||
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≤ 0.1% | ||
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≤ 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:
Molecular Formula: C6H12O6
Molecular Weight: 180.16 g/mol
CAS Number: 59-23-4
D-Galactose Biotech:
- Appears as a white to near-white crystalline product
- Is manufactured under an ICH-Q7 Quality Managed cGMP System
- Manufactured in an enzyme free, hormone free and animal free environment
- Has no known major food allergens (as defined by FDA and WHO)
- The final product nor its raw materials are not derived from nor come into contact with animals, animal parts, animal products, and/or animal byproducts or derivatives.
- Is not subject to genetic modification
- Synonyms: alpha-D-Galactose; Galactose
Shelf Life Policy:
Three-year expiry from the date of manufacture.
Storage and Shipping Conditions:
Please refer to the SDS for storage and shipping conditions.
Package Size:
100g, 500g, 1kg, 5kg, 10kg, 25kg, 50kg
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.