L-Serine CAS 56-45-1 (H-Ser-OH) Assay 98.5~101.0% Factory High Quality

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L-Serine, when dried, contains not less than 98.5% and not more than 101.0% of C3H7NO3.
Description L-Serine occurs as white crystals or a crystalline powder. It has a slight sweet taste. It is freely soluble in water and in formic acid, and practically insoluble in ethanol (99.5). It dissolves in 2 mol/L hydrochloric acid TS.
Identification Determine the infrared absorption spectrum of L-Serine as directed in the potassium bromide disk method under Infrared Spectrophotometry<2.25>, and compare the spectrum with the Reference Spectrum: both spectra exhibit similar intensities of absorption at the same wave numbers.
Optical rotation <2.49> [a]20D: +14.0°~+16.0°(After dry-ing, 2.5 g, 2 mol/L hydrochloric acid TS, 25 mL, 100 mm).
pH <2.54> The pH of a solution prepared by dissolving 1.0 g of L-Serine in 10 mL of water is between 5.2 and 6.2.
Purity (1) Clarity and color of solution-Dissolve 1.0 g of L-Serine in 10 mL of water: the solution is clear and colorless.
(2) Chloride <1.03>-Perform the test with 0.5 g of L-Serine. Prepare the control solution with 0.30 mL of 0.01mol/L hydrochloric acid VS (not more than 0.021%)
(3) Sulfate <1.14> Perform the test with 0.6 g of L-Serine. Prepare the control solution with 0.35 mL of 0.005mol/L sulfuric acid VS (not more than 0.028%).
(4) Ammonium <1.02>-Perform the test with 0.25 g of L-Serine. Prepare the control solution with 5.0 mL of Standard Ammonium Solution (not more than 0.02%).
(5) Heavy Metals <1.07> Proceed with 2.0 g of L-Serine according to Method 1, and perform the test. Prepare the control solution with 2.0 mL of Standard Lead Solution (not more than 10 ppm).
(6) Iron <1.10> Prepare the test solution with 1.0 g of L-Serine according to Method 1, and perform the test according to Method A. Prepare the control solution with 1.0mL of Standard Iron Solution (not more than 10 ppm).
(7) Related Substances-Dissolve 0.10 g of L-Serine in 10mL of water, and use this solution as the sample solution. Pipet 1 mL of the sample solution, add water to make exactly 10 mL. Pipet 1 mL of this solution, add water to makeexactly 50 mL, and use this solution as the standard solution.Perform the test with these solutions as directed under Thin-layer Chromatography<2.03>. Spot 5mLeachofthesamplesolution and standard solution on a plate of silica gel forthin-layer chromatography. Then develop with a mixture of1-butanol, water and acetic acid (100) (3:1:1) to a distance ofabout 10 cm, and dry the plate at 809C for 30 minutes. Sprayevenly a solution of ninhydrinin a mixture of methanol andacetic acid (100) (97:3) (1 in 100) on the plate, and heat at80℃ for 10 minutes: the spot other than the principal spot obtained from the sample solution is not more intense thanthe spot from the standard solution.
Loss on Drying <2.41> Not more than 0.3%(1 g, 105℃, 3 hours).
Residue on Ignition <2.44> Not more than 0.1%(1 g).
Assay Weigh accurately about 0.11 g of L-Serine, previously dried, dissolve in 3 mL of formic acid, add 50 mL of acetic acid (100), and titrate <2.50> with 0.1 mol/L perchloric acid VS (potentiometric titration). Perform a blank determination in the same manner, and make any necessary correction.
Each mL of 0.1 mol/L perchloric acid VS＝10.51 mg of C3H7NO3
Containers and storage Containers-Tight containers.

USP39-NF34
DEFINITION L-Serine contains NLT 98.5% and NMT 101.5% of L-serine (C3H7NO3), calculated on the dried basis.
IDENTIFICATION
A. INFRARED ABSORPTION <197K>
ASSAY
PROCEDURE
Sample: 100mg of Serine
Blank: Mix 3mL of formic acid and 50mL of glacial acetic acid.
Titrimetric system
(See Titrimetry <541>)
Mode: Direct titration
Titrant: 0.1 N perchloric acid VS
Endpoint detection: Potentiometric
Analysis: Dissolve the Sample in 3mL of formic acid and 50mL of glacial acetic acid. Titrate with the Titrant.
Perform the Blank determination.
Calculate the percentage of serine (C3H7NO3) in the sample taken:
Result = {[(VS-VB) xNxF]/W} x100
VS= Titrant volume consumed by the Sample (mL)
VB= Titrant volume consumed by the Blank (mL)
N= actual normality of the Titrant (mEq/mL)
F= equivalency factor, 105.1mg/mEq
W= Sample weight (mg)
Acceptance criteria: 98.5%~101.5% on the dried basis
IMPURITIES
RESIDUEON IGNITION <281>: NMT 0.1%
CHLORIDEAND SULFATE, Chloride <221>
Standard solution: 0.50mL of 0.020 N hydrochloric acid
Sample: 0.73g of Serine
Acceptance criteria: NMT 0.05%
CHLORIDEAND SULFATE, Sulfate <221>
Standard solution: 0.10mL of 0.020 N sulfuric acid
Sample: 0.33g of Serine
Acceptance criteria: NMT 0.03%
IRON <241>: NMT 30ppm
Delete the following:
HEAVY METALS, Method I <231>: NMT 15ppm (Official 1-Jan-201)
RELATED COMPOUNDS
System suitability solution: 0.4mg/mL each of USP L-Serine RS and USP L-Methionine RS in 0.1 N hydrochloric acid
Standard solution: 0.05mg/mL of USP L-Serine RS in 0.1 N hydrochloric acid. [NOTE-This solution has a concentration equivalent to about 0.5% of that of the Sample solution.]
Sample solution: 10mg/mL of Serine in 0.1 N hydrochloric acid
Chromatographic system See Chromatography <621>, Thin-Layer Chromatography.)
Mode: TLC
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture
Application volume: 5μL
Developing solvent system: Butyl alcohol, glacial acebutyl alcohol and 2N acetic acid (95:5)
System suitability
Suitability requirements: The chromatogram of the System suitability solution exhibits two clearly separated spots.
Analysis
Samples: System suitability solution, Standard solution, and Sample solution.
After air-drying the plate, spray with Spray reagent, and heat between 100° and 105° for 15 min. Examine the plate under white light.
Acceptance criteria: Any secondary spot of the Sample solution is not larger or more intense than the principal spot of the Standard solution.
Individual impurities: NMT 0.5%
Total impurities: NMT 2.0%
SPECIFIC TESTS
OPTICAL ROTATION, Specific Rotation <781S>
Sample solution: 100mg/mL in 2N hydrochloric acid
Acceptance criteria: +14.0° to +15.6°
LOSSON DRYING <731>: Dry a sample at 105℃ for 3 h: it loses NMT 0.2% of its weight.
ADDITIONAL REQUIREMENTS
ACKAGINGAND STORAGE: Preserve in well-closed containers.
USP REFERENCE STANDARDS <11>
USP L-Methionine RS
USP L-Serine RS