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Excipient

ICH Q7 GMP Manufactured Product

D-Galactose, Plant Derived

Meets EP/NF, BET*, LEI**, GMP (Large Batch)
Product Code: GALP-3351

<p>*Bioburden and Endotoxin Tested</p> <p>**Low Elemental Impurities</p>

Minimum Order Quantity: Inquire
Lead Time: Inquire

Product Inquiry COAs Spec Sheet

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UNIT SIZE

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500g

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Product Code: GALP-3351

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

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: C₆H₁₂O₆F.W.: 180.16 g/mol

Product Specifications

ANALYSIS

SPECIFICATIONS

Acidity or Alkalinity (EP/NF)

Passes Test

Appearance and Color

White to Almost White Crystalline Powder

Appearance of Solution (EP/NF)

Passes Test

Assay, Anhydrous Basis (EP/NF)

98.0 - 102.0%

Barium (NF)

Passes Test

Endotoxin

< = 2.5 EU/g

Glucose

< = 0.1%

Identification A, IR (EP/NF)

Conforms to Reference Standard

Identification B (EP/NF)

Conforms to Reference Standard

Identification C (EP/NF)

Passes Test

Limit of Lead (NF)

< = 0.5 ppm

Microbial Content

TAMC (EP/NF)

TYMC (NF)

Escherichia coli (NF)

Pseudomonas aeruginosa (NF)

Salmonella species (NF)

Staphylococcus aureus (NF)

< = 100 CFU/g

Absent/g

Absent/10g

Absent/g

Proteins (EP)

< = 0.1 mg/mL

Related Substances

Lactose and 1,6-galactosyl-galactose (NF)

Galacturonic acid (NF)

Dextrose (NF)

Tagatose (NF)

Dulcitol (NF)

Arabinose (NF)

Any Unspecified Impurity (EP/NF)

Sum of Impurities A and B (EP)

Total Impurities (EP/NF)

< = 0.6%

< = 0.2%

< = 1.0%

Specific Optical Rotation, 20°C (NF)

+78.0º to +81.5º

Residue on Ignition / Sulfated Ash (EP/NF)

< = 0.1%

Trace Metals

Aluminum (Al)

Cadmium (Cd)

Cobalt (Co)

Chromium (Cr)

Copper (Cu)

Iron (Fe)

Manganese (Mg)

Molybdenum (Mo)

Nickel (Ni)

Selenium (Se)

Vanadium (V)

Zinc (Zn)

< = 0.400 ppm

< = 0.010 ppm

< = 0.050 ppm

< = 0.025 ppm

< = 0.200 ppm

< = 0.025 ppm

< = 0.050 ppm

< = 0.200 ppm

Water, KF (EP/NF)

< = 1.0%

Residual Solvents

Ethanol

Isopropanol

Methanol

Methyl Isobutyl Ketone

< = 500 ppm

< = 5000 ppm

< = 100 ppm

< = 500 ppm

Printable Version

Key Product Features:

The manufacturing of D-Galactose, Plant Derived, GALP-3351 is performed at BioSpectra’s Bangor, PA facility.
Appears as a white to almost white crystalline powder
Manufactured in accordance with ICH Q7
Manufactured in an enzyme free, hormone free, and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: D-Galactopyranose

Storage & Shipping:

Refer to SDS.

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Package Sizes:

5kg, 10kg, 25kg, and 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.