GMP Manufactured Product
Glutamine(L)
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
Product Specifications
| 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
General Product Description:
- L-Glutamine is produced at our cGMP platform in India and then shipped to our Bangor, PA facility where it is tested and repackaged under cGMP conditions.
- L-Glutamine is a White Crystalline product.
- Molecular Formula: C5H10N2O3 • 2H2O
- Molecular Weight: 146.14 g/mol.
- CAS Number: 56-85-9
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all L-Glutamine, LGLM-4250 at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
- L-Glutamine manufactured at our cGMP platform in India and any raw materials used in the manufacture of L-Glutamine at BioSpectra are not subject to genetic modification.
- Synonyms: (S)-2,5-Diamino-5-oxopentanoic acid, L- Glutamic acid 5-amide.
GMP Compliance:
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.
Retest Date:
The recommended retest period for L-Glutamine is two years from the date of manufacture.
Storage and Shipping Conditions:
Ship and Store in ambient temperature.
Package Sizes:
10kg, 25kg and 50kg pails.
Country of Origin
India
This product is then repacked and retested under cGMP at our Bangor USA cGMP FDA Regulated Facility.
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.