Pharm-Rx L-Lysine HCL

Labetalol Hydrochloride contains not less than 97.5 percent and not more than 101.0 percent of C₁₉H₂₄N₂O₃ · HCl, calculated on the dried basis. Packaging and storage—Preserve in tight, light-resistant containers. Store at 25°, excursions permitted between 15° and 30°. USP Reference standards á11ñ— USP Labetalol Hydrochloride RS Identification— Change to read: A: Spectroscopic Identification Tests á197ñ, Infrared Spectroscopy: 197M (CN 1-May-2020). B: It responds to the tests for Chloride á191ñ. pH á791ñ: between 4.0 and 5.0, in a solution (1 in 100). Loss on drying á731ñ: Dry it in a vacuum at 105° for 4 hours: it loses not more than 1.0% of its weight. Residue on ignition á281ñ: not more than 0.1%. Chromatographic purity— Detection reagent—Transfer 2.5 g of cadmium acetate to a 500-mL volumetric flask, add 10 mL of glacial acetic acid, dilute with alcohol to volume, and mix. Just prior to use, prepare a 0.2 in 100 solution of ninhydrin in the cadmium acetate solution for use as the Detection reagent. Solvent mixture—Prepare a solution of methanol and water (4:1), and mix. Ammonium chloride reference solution—Dissolve 60 mg of ammonium chloride in 10.0 mL of water, and mix. Standard stock solution—Dissolve USP Labetalol Hydrochloride RS in Solvent mixture, and mix to obtain a solution having a known concentration of 40 mg per mL. Standard solution 1—Quantitatively dilute a portion of the Standard stock solution with Solvent mixture to obtain a solution having a known concentration of 0.2 mg per mL. Standard solution 2—Quantitatively dilute a portion of the Standard solution 1 with Solvent mixture to obtain a solution having a known concentration of 0.1 mg per mL. Test solution—Dissolve 200 mg of Labetalol Hydrochloride in 5.0 mL of Solvent mixture