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Product Category

Excipient

ICH-Q7 GMP Manufactured Product

L-GLUTAMINE, USP, LBLE,
GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: LGLM-3250

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Intended For Use As An Excipient


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.

Product Specifications

  ANALYSIS SPECIFICATIONS
Assay (dried basis)  
98.5% - 101.5%
Appearance and Color  
White crystals or crystalline powder
Chloride and Sulfate, Chloride  
≤ 0.05%
Chloride and Sulfate, Sulfate ≤ 0.03%

Endotoxin

  
33.33 EU/g (S 1 EU/mL at 30 mg/mL)
Identification (IR)

Passes Test
Iron  

≤ 10 ppm
Loss on Drying  
≤ 0.30%
Optical Rotation @ 20°C  
+6.3° to +7.3°
Residue on Ignition  
≤ 0.10%
Related Compounds No secondary spot of the Sample solution is larger or more intense than the principal spot of the Standard solution (≤ 0.5%)
Printable Version
List of C of As files
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COAs and Tech Docs

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LGLM-3250

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

General Product Description:

  • The manufacturing of Bio Excipient Grade L-Glutamine, LGLM-3250 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of LGLM-3250 is cleaned in accordance with BioSpectra's Process Cleaning Validation Master Plan.
  • 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-3250 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 BioSpectra 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 Excipient Grade L-Glutamine, LGLM-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of L-Glutamine is not suitable to be used as an Active Pharmaceutical Ingredient, 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.

Additional Packaging Information

https://www.biospectra.us/technical/packaging