Excipient
ICH-Q7 GMP Manufactured ProductL-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 | ||
|---|---|---|---|
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98.5% - 101.5% | ||
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White crystals or crystalline powder | ||
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≤ 0.05% | ||
| Chloride and Sulfate, Sulfate | ≤ 0.03% | ||
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33.33 EU/g (S 1 EU/mL at 30 mg/mL) | ||
| Identification (IR) |
Passes Test |
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≤ 10 ppm |
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≤ 0.30% | ||
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+6.3° to +7.3° | ||
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≤ 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%) |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
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| indicates 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. |
| List of C of As files |
|---|
| No files available right now. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
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