ICH-Q7 GMP Manufactured Product
Galactose(D)
*Low Bioburden, Low Endotoxin, **Low Elemental Impurities
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: C6H12O6
Sol. In H2O (g/L): 600
F.W.: 180.16 g/mol
pKa @ 25˚C: 12.4
Product Specifications:
|
NF COMPENDIA |
|||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
Passes Test | ||
|
Passes Test |
||
|
98.0% – 102.0% | ||
|
Barium |
Passes Test |
||
|
Conforms to Reference | ||
|
Passes Test | ||
|
Passes Test | ||
|
1Limit of Lead |
≤ 0.5 ppm |
||
|
Absent Absent Absent Absent 3≤ 100 CFU/g ≤ 100 CFU/g |
||
|
≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.2% ≤ 1.0% |
||
|
≤ 0.1% |
||
|
+78.0º to +81.5º |
||
|
≤ 1.0% | ||
|
EP COMPENDIA |
|||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
Passes Test | ||
|
White to almost white, crystalline or finely granulated powder |
||
|
Passes Test | ||
|
398.0 – 102.0% | ||
|
Conforms to Reference | ||
|
Passes Test | ||
|
Passes Test | ||
|
≤ 100 CFU/g | ||
|
≤ 0.1 mg/mL | ||
|
≤ 1.0% ≤ 0.3% ≤ 2.0% |
||
|
≤ 0.1% | ||
|
≤ 1.0% | ||
| ADDITIONAL ANALYSES | |||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
≤ 2.5 EU/g | ||
|
≤ 0.1% |
||
|
≤ 400 ppb ≤ 10 ppb ≤ 50 ppb ≤ 50 ppb ≤ 25 ppb ≤ 200 ppb ≤ 25 ppb ≤ 50 ppb ≤ 50 ppb ≤ 50 ppb ≤ 50 ppb ≤ 200 ppb |
||
|
≤ 500 ppm | ||
|
≤ 5000 ppm | ||
|
≤ 100 ppm | ||
|
≤ 500 ppm | ||
Printable Version
General Product Description:
- The Manufacturing of D-Galactose, Plant Derived GALP-3251 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-3251 manufactured at BioSpectra and its raw materials are allergen free.
- BioSpectra certifies that all D-Galactose, Plant Derived GALP-3251 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-3251 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.