D-Galactose BIOTECH PLANT DERIVED, EP, NF, GMP

GMP Biotech Product

D-GALACTOSE BIOTECH

Plant Derived, EP, NF, LBLE*, GMP
Product Code: GALP-4250

*Low Bioburden, Low Endotoxin

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Product Code: GALP-4250

Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

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 meets multicompendial specifications.

Formula: C₆H₁₂O₆F.W.: 180.16 g/mol
CAS #: 59-23-4

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)

< = 0.1mg/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)

+78.0° to +81.5°

Residue on Ignition / Sulfated Ash (NF/EP)

< = 0.1%

Residual

Solvents

Ethanol

Isopropanol

Methanol

Methyl Isobutyl Ketone

< = 500 ppm

< = 5000 ppm

< = 100 ppm

< = 500 ppm

Water, KF (EP/NF)

< = 1.0%

Printable Version

Key Product Features:

Appears as a white to almost white crystalline powder
Manufactured in accordance with IPEC
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 animals, animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: D-Galactopyranose; alpha-D-Galactose

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).

Storage & Shipping:

Refer to SDS.

Package Sizes:

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.