6-Aminohexanoic Acid CAS 60-32-2 (ε-​Aminocaproic Acid) Assay 98.5~100.5% Factory

6-Aminohexanoic Acid (ε-​Aminocaproic Acid) (CAS: 60-32-2) AJI97 Test Method
ε-​Aminocaproic Acid, when calculated on the anhydrous basis, contains not less than 98.5 percent and not more than 100.5 percent of ε-​Aminocaproic Acid (C6H13NO2).
Description: White crystals or crystalline powder, slightly bitter taste.
Freely soluble in water and in glacial acetic acid, slightly soluble in methanol, practically insoluble in ethanol.
Solubility (H2O, g/100g): Freely soluble in water
Identification: Compare the infrared absorption spectrum of the sample with that of the standard by potassium bromide disc method.
Specifications:
State of Solution (Transmittance): 0.5g in 10ml of H2O, spectrophotometer, 430nm, 10mm cell thickness.
Chloride (Cl): 0.7g, A-1, ref: 0.40ml of 0.01mol/L HCl
Ammonium (NH4): B-1
Sulfate (SO4): 1.2g, (1), ref: 0.50ml of 0.005mol/L H2SO4
Iron (Fe): 0.5g, ref: 1.5ml of Iron Std. (0.01mg/ml)
Heavy Metals (Pb): 2.0g, (1), pH=7, ref: 2.0ml of Pb Std. (0.01mg/ml)
Arsenic (As2O3): 2.0g, (1), ref: 2.0ml of As2O3 Std.
Other Amino Acids: Test sample: 100μg, B-1-a, control; ε-​Acp 0.6μg
Water: 500mg, methanol: ethyleneglycol (1:2) for Karl Fischer Method, A, for 15 minutes.
Residue on Ignition (Sulfated): AJI Test 13
Assay: Sample calculated on the anhydrous basis, 130mg, (1), 3ml of formic acid, 50ml of glacial acetic acid, 0.1mol/L HCLO4 1ml=13.117mg C6H13NO2
pH: 1.0g in 10ml of H2O
Recommended storage limit and condition: Preseved tight containers at controlled room temperature (2 years).

6-Aminohexanoic Acid (ε-​Aminocaproic Acid) (CAS: 60-32-2) USP35 Test Method
Aminocaproic Acid contains not less than 98.5 percent and not more than 101.5 percent of C6H13NO2, calculated on the anhydrous basis.
Packaging and storage-Preserve in tight containers. Store at room temperature.
USP Reference standards <11>-
USP Aminocaproic Acid RS
Identification, Infrared Absorption <197K>.
Water, Method I <921>: not more than 0.5%.
Residue on ignition <281>: not more than 0.1%.
Heavy metals, Method II <231>: 0.002%.
Assay-
Solution A-Transfer 0.55 g of sodium 1-heptanesulfonate to a 1000-mL volumetric flask, dissolve in and dilute with water to volume, and mix.
Mobile phase-Transfer 10 g of monobasic potassium phosphate to a 1000-mL beaker, dissolve in 300 mL of Solution A, add 250 mL of methanol, followed by another 300 mL of Solution A, and mix. Adjust the mixture with phosphoric acid to a pH of 2.2. Transfer the whole mixture to a 1000-mL volumetric flask, dilute with Solution A to volume, and mix. Filter and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Internal standard solution-Prepare a solution of methionine in water containing 1.25 mg per mL.
Standard preparation-Dissolve an accurately weighed quantity of USP Aminocaproic Acid RS in water to obtain a Stock solution having a known concentration of 12.5 mg per mL. Transfer 5.0 mL of the Stock solution to a 100-mL volumetric flask, add 2.0 mL of the Internal standard solution, dilute with water to volume, and mix.
Assay preparation-Transfer an accurately weighed quantity of 1.25 g of Aminocaproic Acid to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, add 2.0mL of Internal standard solution, dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)-The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 15-cm column that contains packing L1 and is maintained at 30°. The flow rate is about 0.7 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative retention times are about 0.76 for aminocaproic acid and 1.0 for methionine; the resolution, R, between aminocaproic acid and methionine is not less than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure-Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, and allow the Assay preparation to elute for not less than two times the retention time of aminocaproic acid. Record the chromatograms, and measure all the peak responses. Calculate the quantity, in g, of C6H13NO2 in the portion of Aminocaproic Acid taken by the formula:
2C(RU / RS)
in which C is the concentration, in mg per mL, of USP Aminocaproic Acid RS in the Standard preparation; and RU and RS are the ratios of the aminocaproic acid peak response to the internal standard peak response obtained from the Assay preparation and the Standard preparation, respectively.