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Specification: State of solution: Clear and colorless Specific Rotation []D20: -15.5 to -17.5 Assay: 98.0% to 101.0% Loss on drying: 0.50% max. Chloride [Cl-]: 0.02% max. Ammonium [NH4]: 0.02% max. Sulfate [SO4]: 0.03% max. Impurities A.B.E. 0.5% max. Impurities C.D.. 1.0% max. Iron [Fe]: 10ppm max. Heavy metals [Pb]: 10ppm max. Arsenic [As2O3]: 2ppm max. Residue on ignition [sulfated]: 0.10% max

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The primary goal was to identify high-risk patient populations requiring intensified monitoring in this resource-limited region with distinct demographic challenges including multi-ethnic populations and limited healthcare access