GMP Manufactured Product
Glutamine is an α-amino acid that is used in the biosynthesis of proteins. This product is synthesized and purified under full GMP conditions for use in GMP Pharmaceutical Production. L-Glutamine is used as a supplement energy source for certain types of mammalian cells and is used in other biopharmaceutical manufacturing applications.
CAS #: 56-85-9
Formula: C5H10N2O3 • 2H2O
pH (6M) @ 20°C: 4.5 - 6.0
Sol. In H2O (g/L): 36
F.W.: 146.14 g/mol
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
98.5% - 101.5% | ||
|
White crystals or crystalline powder | ||
|
≤ 0.05% | ||
| Identification A (IR) |
Passes Test |
||
|
≤ 10 ppm |
||
|
≤ 0.3% | ||
|
+6.3° to +7.3° | ||
|
≤ 0.10% | ||
| Related Compounds | ≤ 0.5% | ||
| Sulfate | ≤ 0.03% |
Printable Version
Bio Pharma Grade L-Glutamine, LGLM-4250 is suitable for use as an excipient. It is manufactured in accordance with International Organization for Standardization (ISO) registered Quality Managed Systems. This grade of L-Glutamine is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
The recommended retest period for L-Glutamine is two years from the date of manufacture.
Ship and Store in ambient temperature.
10kg, 25kg and 50kg pails.
India
This product is then repacked and retested under cGMP at our Bangor USA cGMP FDA Regulated Facility.
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.