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L(+)-Glutamine kit 98.5-101.5% (dry basis) USP, Multi-Compendial

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Management of Change (MOC) category = R

2078-B1EA 46146.55 INR InStock
2078-B1 2078-B2 2078-SA
L(+)-Glutamine kit 98.5-101.5% (dry basis) USP, Multi-Compendial
L(+)-Glutamine


Formula: C₅H₁₀N₂O₃
MW: 146.15 g/mol
Boiling Pt: 355 °C (1013 hPa)
Melting Pt: 185…186 °C
Density: 1.5326 g/cm³ (130 °C)
Storage Temperature: Ambient
 MDL Number: MFCD00008044
CAS Number: 56-85-9
EINECS: 200-292-1
Merck Index: 13,04484
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Specification Test Results
Meets J.P. Chemical Specifications
Meets U.S.P Requirements
GMP Manufactured Product
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (C₅H₁₀N₂O₃) (dried basis) 98.5 - 101.5 %
USP - Identification Passes Test
USP - Specific Rotation [Å]²º^D (+) 6.3 - 7.3 Degree
USP - Loss on Drying at 105°C ≤ 0.3 %
USP - Residue after Ignition ≤ 0.3 %
USP - Chloride (Cl) ≤ 0.05 %
USP - Sulfate (SO₄) ≤ 0.03 %
USP - Iron (Fe) ≤ 0.003 %
USP - Related Compounds 0.5% max
JP - Assay (C₅H₁₀N₂O₃) (dried basis) 99.0 - 101.0 %
JP - Identification Passes Test
JP - Specific Rotation [Å]²º^D (+) 6.3 - 7.3 Degree
JP - Loss on Drying at 105°C ≤ 0.30 %
JP - Residue after Ignition ≤ 0.1 %
JP - Chloride (Cl) ≤ 0.021 %
JP - Sulfate (SO₄) ≤ 0.028 %
JP - Iron (Fe) ≤ 10 ppm
JP - Heavy Metals (as Pb) ≤ 10 ppm
JP - Related substances Passes Test
JP - pH 4.5 - 6.0
JP - Clarity and Color of Solution Passes Test
JP - Ammonium ≤ 0.1 %
Solubility of 3% Solution at 30°C Passes Test
Solubility of 3.5% Solution at 30°C Passes Test
Identification (by IR) Passes Test
Endotoxin Concentration (EU/mg) ≤ 0.06
Endotoxin Concentration, IU/mg Passes Test
No Class 1,2,3 or other solvents are used or produced in the
manufacturing or purification of the product.
Elemental Impurities (USP (232), EP 5.20) - Information on elemental
impurities for this product is available on the associated Product
Regulatory Data Sheet and elemental impurity profile report.
This product has been filled to +/- 1% of the stated net weight.

 

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