D-Galactose | GMP | Excipient | Plant Derived

Excipient

ICH-Q7 GMP Manufactured Product

Galactose(D)

Plant Derived, EP, NF, LBLE*, Ultra Low LEI**, GMP Grade, (Large Batch - Up to 1000kg)
Product Code: GALP-3351

*Low Bioburden, Low Endotoxin, **Low Elemental Impurities

Minimum Order Quantity: 25kg
Lead Time: Up to 6-months

Product Inquiry COAs Spec Sheet

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: GALP-3351

Intended for Use in Pharma Mfg. Requiring ICH-Q7 Excipient Grade Quality & Regulatory Compliance

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: C₆H₁₂O₆Sol. In H₂O (g/L): 350
F.W.: 180.16 g/mol
pK_a @ 25˚C: 12.4

Product Specifications:

NF COMPENDIA

ANALYSIS

SPECIFICATIONS

²Acidity

Passes Test

²Appearance of Solution

Passes Test

¹Assay

98.0% – 102.0%

Barium

Passes Test

²Identification A

Conforms to Reference

¹Identification B

Passes Test

²Identification C

Passes Test

¹Limit of Lead

≤ 0.5 ppm

²Microbial Content

Escherichia coli

Pseudomonas aeruginosa

Salmonella species

Staphylococcus aureus

TAMC

TYMC

Absent

³≤ 100 CFU/g

≤ 100 CFU/g

¹Related Substances

Lactose and 1,6-galactosyl-galactose
Galacturonic acid
Dextrose
Tagatose
Dulcitol
Arabinose
Any Unspecified Impurity
Total Impurities

≤ 0.6%

≤ 0.2%

≤ 1.0%

Residue on Ignition

≤ 0.1%

Optical Rotation, Specific Rotation @ 20°C

+78.0º to +81.5º

²Water

≤ 1.0%

EP COMPENDIA

ANALYSIS

SPECIFICATIONS

²Acidity or Alkalinity

Passes Test

Appearance

White to almost white, crystalline or finely granulated powder

²Appearance of Solution

Passes Test

¹Assay

³98.0 – 102.0%

²Identification A

Conforms to Reference

¹Identification B

Passes Test

²Identification C

Passes Test

²Microbial Content

TAMC

≤ 100 CFU/g

Proteins

≤ 0.1 mg/mL

¹Related Substances

Sum of Impurities A and B

Unspecified Impurities: for each impurity

Total Impurities

≤ 1.0%

≤ 0.3%

≤ 2.0%

Sulfated Ash

≤ 0.1%

²Water

≤ 1.0%

ADDITIONAL ANALYSES

ANALYSIS

SPECIFICATIONS

Endotoxins

≤ 2.5 EU/g

¹Glucose

≤ 0.1%

Trace Metals

Aluminum (Al)

Cadmium (Cd)

Cobalt (Co)

Chromium (Cr)

Copper (Cu)

Iron (Fe)

Manganese (Mn)

Molybdenum (Mo)

Nickel (Ni)

Selenium (Se)

Vanadium (V)

Zinc (Zn)

≤ 400 ppb

≤ 10 ppb

≤ 50 ppb

≤ 25 ppb

≤ 200 ppb

≤ 25 ppb

≤ 50 ppb

≤ 200 ppb

¹Residual Ethanol

≤ 500 ppm

¹Residual Isopropanol

≤ 5000 ppm

¹Residual Methanol

≤ 100 ppm

¹Residual Methyl Isobutyl Ketone

≤ 500 ppm

Printable Version

General Product Description:

The Manufacturing of D-Galactose, Plant Derived GALP-3351 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment.
D-Galactose, Plant Derived is a white to almost white crystalline powder
Molecular Formula: C₆H₁₂O₆
Molecular Weight: 180.16 g/mol
CAS Number: 59-23-4
BioSpectra certifies that all D-Galactose, Plant Derived GALP-3351 manufactured at BioSpectra and its raw materials are allergen free.
BioSpectra certifies that all D-Galactose, Plant Derived GALP-3351 manufactured
at BioSpectra, and its raw materials, are not derived from or come in contact with animal parts, products, and/or byproducts.
D-Galactose, Plant Derived manufactured at BioSpectra and any raw materials used in the manufacture of D-Galactose, Plant Derived at BioSpectra are not subject to genetic modification.
Synonyms: D-Galactopyranose

GMP Compliance:

Bio Excipient Grade D-Galactose, Plant Derived GALP-3351 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.

Retest Date:

The recommended retest period for D-Galactose, Plant Derived is two years from the date of manufacture.

Storage and Shipping Conditions:

Keep container tightly closed and store in a clean, dry and well-ventilated area. Store in the original container.

Package Sizes:

10kg & 25kg pails and 50kg drum.

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.