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

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
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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formula-image
formula-image

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