NF Compendia
ANALYSIS
|
SPECIFICATIONS
|
|
Passes Test |
|
Passes Test
|
|
98.0 – 102.0% |
|
Conforms to Reference |
|
Passes Test |
|
Passes Test |
2Microbial Content |
Escherichia coli
Pseudomonas aeruginosa
Salmonella species
Staphylococcus aureus
TAMC
TYMC
|
|
Absent
Absent
Absent
Absent
3≤ 50 CFU/g
≤ 50 CFU/g
|
1Related Substances |
Glucose (HPLC)4
Lactose and 1,6-galactosyl-galactose
Galacturonic acid
Dextrose
Tagatose
Dulcitol
Arabinose
Any Unspecified Impurity
Total Impurities
|
|
≤ 0.1%
≤ 0.3%
≤ 0.2%
≤ 0.6%
≤ 0.2%
≤ 0.2%
≤ 0.3%
≤ 0.2%
≤ 0.8%
|
|
≤ 0.05%
|
Optical Rotation, Specific Rotation @ 20°C
|
|
|
+78.0º to +81.5º
|
|
≤ 1.0% |
1Alternate Validated Method, 2Analyses are Harmonized, 3Specification is more stringent than Compendia Monograph
* = Low Bioburden, Low Endotoxin product, ** = Low Elemental Impurities product
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 |
|
≤ 50 CFU/g |
|
≤ 0.1 mg/mL |
1Related Substances |
Sum of Impurities A and B
Unspecified Impurities: for each impurity
Total Impurities
|
|
≤ 1.0%
≤ 0.2%
≤ 0.8%
|
|
≤ 0.1% |
|
≤ 1.0% |
1Alternate Validated Method, 2Analyses are Harmonized, 3Specification is more stringent than Compendia Monograph
Additional Analyses
ANALYSIS
|
SPECIFICATIONS
|
|
≤ 1.0 EU/g |
Trace Metals (USP <232> <233>)
|
Aluminum (Al)
Arsenic (As) (inorganic)
Barium (Ba) (NF)4
Cadmium (Cd)
Cobalt (Co)
Chromium (Cr)
Copper (Cu)
Iron (Fe)
Lead (PB) (NF)4
Manganese (Mn)
Mercury (Hg) (inorganic)
Molybdenum (Mo)
Nickel (Ni)
Selenium (Se)
Tungsten (W)
Vanadium (V)
Zinc (Zn)
|
|
≤ 63 ppb
≤ 50 ppb
≤ 63 ppb
≤ 10 ppb
≤ 50 ppb
≤ 50 ppb
≤ 25 ppb
≤ 200 ppb
≤ 50 ppb
≤ 25 ppb
≤ 50 ppb
≤ 50 ppb
≤ 50 ppb
≤ 50 ppb
≤ 50 ppb
≤ 50 ppb
≤ 200 ppb
|
|
≤ 200 ppm3 |
|
≤ 500 ppm3 |
|
≤ 100 ppm3 |
1Residual Methyl Isobutyl Ketone |
|
|
≤ 500 ppm |
1Alternate Validated Method, 2Analyses are Harmonized, 3Specification is more stringent than Compendia Monograph, 4NF Compendial Method
Printable Version
General Product Description:
- The Manufacturing of D-Galactose, Plant Derived GA3251 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 GA3251 manufactured at BioSpectra and its raw materials are allergen free.
- BioSpectra certifies that all D-Galactose, Plant Derived GA3251 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 GA3251 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured non-Sterile Excipient for use in further Manufacturing. This Grade of D-Galactose, Plant Derived is not suitable to be used as a Sterile or Injectable Excipient, Active Pharmaceutical Ingredient, Drug Product or Household Item.
Expiration/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.