Galactose(D)

Excipient

ICH-Q7 GMP Manufactured Product

Galactose(D)

PLANT DERIVED, EP, NF, LBLE, ULTRA LOW LEI, GMP
Product Code: GALP-3252

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: GALP-3252

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

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.

CAS #: 59-23-4
Formula: C₆H₁₂O₆Sol. In H₂O (g/L): 650
F.W.: 180.16 g/mol

Product Specifications:

NF COMPENDIA

ANALYSIS

SPECIFICATIONS

Acidity or Alkalinity

Acidity or Alkalinity (EP)

Acidity (NF)

Passes Test

Appearance

White to almost white,
crystalline or finely
granulated powder

Appearance (EP/NF)

Passes Test

Assay, Anhydrous Basis HPLC (EP/NF)

98.0% – 102.0%

Endotoxins

< 1.0 EU/g

Glucose

< 0.2%

Identification A (EP/NF)

Conforms to Reference

Identification B (EP/NF)

Passes Test

Identification C (EP/NF)

Passes Test

Microbial Content

TAMC (EP/NF)

TYMC (NF)

Escherichia coli (NF)

Pseudomonas aeruginosa (NF)

Salmonella species (NF)

Staphylococcus aureus (NF)

< 50 CFU/g

Absent

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)

< 0.3%

< 0.2%

< 0.3%

< 0.2%

< 1.0%

< 0.8%

Residue on Ignition

≤ 0.05%

Optical Rotation, Specific Rotation @ 20°C

+78.0º to +81.5º

Sulfated Ash (EP)

≤ 0.1%

Residual Ethanol

≤ 200 ppm

Residual Isopropanol

≤ 5000 ppm

Residual Methanol

≤ 200 ppm

Residual Methyl Isobutyl Ketone

≤ 500 ppm

Water, KF (EP/NF)

≤ 1.0%

Trace Metals

Aluminum (Al)

Arsenic (As)

Barium (Ba)

Cadmium (Cd)

Cobalt (Co)

Chromium (Cr)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Manganese (Mn)

Molybdenum (Mo)

Nickel (Ni)

Selenium (Se)

Vanadium (V)

Zinc (Zn)

≤ 63 ppb

≤ 50 ppb

≤ 63 ppb

≤ 50 ppb

≤ 250 ppb

≤ 63 ppb

≤ 250 ppb

≤ 50 ppb

≤ 63 ppb

≤ 50 ppb

≤ 63 ppb

≤ 250 ppb

Printable Version

General Product Description:

Appears as a white to near-white crystalline powder
Manufactured under an ICH-Q7 Quality Managed cGMP System
Manufactured in a hormone free and animal free environment
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/derivatives.
Is not subject to genetic modification
Synonyms: alpha-D-Galactose; Galactose

Standard Lead Time:

If stock: 1-month / If no stock: 6-months

Storage and Shipping Conditions:

Refer to SDS.

Standard Shelf Life Policy:

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

Package Sizes:

5kg, 10kg, 25kg, 50kg.

Minimum Order Quantity:

25kg

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.