GALACTOSE (D) BIOTECH

GMP Biotech Product

GALACTOSE (D) BIOTECH

PLANT DERIVED, EP, NF, LBLE*, GMP
Product Code: GALP-4250

*Low Bioburden, Low Endotoxin

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Price per unit (USD)		Price per kilogram (USD)
1kg	2-5kg (1kg ea)	1x5kg	1x10kg
$465 ea.	$460 ea.	$455 /kg	$450 /kg

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

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

Product Specifications:

ANALYSIS

SPECIFICATIONS (EP)

Acidity or Alkalinity

Acidity or Alkalinity (EP)

Acidity (NF)

Passes Test

Appearance

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

Identification A (EP, NF)

Conforms to Reference Standard

Identification B (EP, NF)

Passes Test

Identification C (EP, NF)

Passes Test

Proteins (EP)

≤ 0.1 mg/ml

Sulfated Ash (EP)

≤ 0.1%

Water, KF (NF/EP)

≤ 1.0%

Limit of Lead (NF)

≤ 0.5 ppm

Microbial Content (NF)

Escherichia coli (NF)

Pseudomonas aeruginosa (NF)

Salmonella species (NF)

Staphylococcus aureus (NF)

TAMC (EP/NF)

TYMC (NF)

Absent

≤ 100 CFU/g

Related Substances (NF)

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%

Residue on Ignition (NF)

≤ 0.1%

Optical Rotation, Specific Rotation (NF)

+78.0° to +81.5°

Endotoxins

≤ 2.5 EU/g

Glucose

≤ 0.1%

Residual Ethanol

≤ 500 ppm

Residual Isopropanol

≤ 5000 ppm

Residual Methanol

≤ 100 ppm

Residual Methyl Isobutyl Ketone

≤ 500 ppm

Printable Version

General Product Description:

Molecular Formula: C₆H₁₂O₆Molecular 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:

Each Certificate of Analysis (CofA) will contain a 2-year retest/recertification date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Size:

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.