Arginine

Arginine, also known as L-Arginine is an α-amino acid that is used in the biosynthesis of proteins. L-arginine is an amino acid that helps the body make proteins. It can be obtained naturally in the diet and is also found in dietary supplement form. Foods rich in L-arginine include plant and animal proteins, such as dairy products, meat, poultry, fish, and nuts.

General Properties and Specifications of L-Arginine, low endotoxin, low metal:
Appearance: White or almost white, crystalline powder or colourless crystals, hygroscopic.
Odor: Odorless
Assay: 99% minimum.
Melting point: 222C literature.
Solubility: It is soluble in water, insoluble in ether, and sparingly soluble in alcohol.
Storage: Store at 4C

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Specifications of Arginine USP Grade:
C6H14N4O2 --- 174.20
L-Arginine --- [CAS 74-79-3].

DEFINITION
Arginine contains NLT 98.5% and NMT 101.5% of C6H14N4O2 , as l-arginine, calculated on the dried basis.

IDENTIFICATION
Infrared Absorption

ASSAY
To pass the test.
Acceptance criteria: 98.5%–101.5% on the dried basis
Residue on Ignition: NMT 0.3%
Chloride and Sulfate, Chloride: A 1.0-g portion shows no more chloride than corresponds to 0.70 mL of 0.020 N hydrochloric acid (0.05%).
Chloride and Sulfate, Sulfate: A 1.0-g portion shows no more sulfate than corresponds to 0.30 mL of 0.020 N sulfuric acid (0.03%).
Iron: NMT 30 ppm
Organic Impurities:
To pass the test.
Acceptance criteria
Individual impurities: Any secondary spot from the Sample solution is not larger or more intense than the principal spot from the Standard solution, NMT 0.5%
Total impurities: NMT 2.0%
Optical Rotation, Specific Rotation: +26.3° to +27.7°
Loss on Drying: Dry a sample at 105° for 3 h: it loses NMT 0.5% of its weight.
Packaging and Storage: Preserve in well-closed containers.

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Specifications of Arginine BP Ph Eur Grade:
C6H14N4O2 --- 174.2 --- CAS 74-79-3
Action and use: Amino acid; nutrient.

DEFINITION
(2S)-2-Amino-5-guanidinopentanoic acid.
Product of fermentation or of protein hydrolysis.
Content: 98.5 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, crystalline powder or colourless crystals, hygroscopic.
Solubility: Freely soluble in water, very slightly soluble in ethanol (96 per cent).

IDENTIFICATION
First identification: A, C
Second identification: A, B, D, E
A. Specific optical rotation (see Tests).
B. Solution S (see Tests) is strongly alkaline.
C. Infrared absorption spectrophotometry.
Comparison arginine CRS.
If the spectra obtained show differences, dry the substance to be examined and the reference substance in an oven at 105C and record new spectra.
D. Thin-layer chromatography:
To pass the test.
Results The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.
E. Dissolve about 25 mg in 2 mL of water. Add 1 mL of α-naphthol solution and 2 mL of a mixture of equal volumes of strong sodium hypochlorite solution and water. A red colour develops.

TESTS
Solution S: Dissolve 2.5 g in distilled water and dilute to 50 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Specific optical rotation: + 25.5 to + 28.5 (dried substance).
Dissolve 2.00 g in hydrochloric acid and dilute to 25.0 mL with the same acid.
Ninhydrin-positive substances:
To pass the test.
Limits:
-any ninhydrin-positive substance: for each impurity, maximum 0.2 per cent;
-total: maximum 0.5 per cent;
-reporting threshold: 0.05 per cent.
Chlorides: Maximum 200 ppm.
Sulfates: Maximum 300 ppm.
Ammonium: To pass the test.
Iron: Maximum 10 ppm.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

STORAGE
In an airtight container, protected from light.

IMPURITIES
Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other/unspecified impurities. It is therefore not necessary to identify these impurities for demonstration of compliance.
: A, B, C.
A. (2S)-2,6-diaminohexanoic acid (lysine),
B. (2S)-2-amino-5-(carbamoylamino)pentanoic acid (citrulline),
C. (2S)-2,5-diaminopentanoic acid (ornithine).

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Specifications of L-Arginine FCC Food Grade:
L-2-Amino-5-guanidinovaleric Acid
C6H14N4O2 Formula wt 174.20
CAS: [74-79-3]

DESCRIPTION
L-Arginine occurs as white crystals or as a white crystalline powder. It is soluble in water, insoluble in ether, and sparingly soluble in alcohol. It is strongly alkaline, and its water solutions absorb carbon dioxide from the air.
Function: Nutrient.

REQUIREMENTS
Identification: The infrared absorption spectrum of the sample exhibits relative maxima at the same wavelengths as those of a typical spectrum as shown in the section on Infrared Spectra, using the same test conditions as specified therein.
Assay: Not less than 98.5% and not more than 101.5% of C6H14N4O2, calculated on the dried basis.
Lead: Not more than 5 mg/kg.
Loss on Drying: Not more than 1.0%.
Optical (Specific) Rotation: [α]D20°: Between +26.0° and +27.9°, calculated on the dried basis; or [α]D25°: Between +25.8° and +27.7°, calculated on the dried basis.
Residue on Ignition: Not more than 0.2%.

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