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Estradiol

Appearance:White or creamy white, small crystals or crystalline powder Identification (A, IR;B, UV) : Meets the requirements Melting range:173-179oC Specific rotation :+76 - +83o Water:3.5%max Chromatographic Purity any individual impurity: NMT 0.5%;total impurities: NMT 1.0% Assay (on anhydrous basis):97.0-103.0% Residual solvents Methanol: 3000ppm max Ethanol: 5000ppm max Micro:90% below 30microns
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Mefenamic Acid

Identification : meets the requirementsLoss on drying :1.0% maxResidue on ignition :0.1% maxHeavy metals:0.002% maxChromatographic purityany individual impurity : 0.1% maxtotal impurities :0.5% maxAssay (on the dried basis): 98.0102.0%Residual solventsToluene : 0.089% max.N, N-dimethylformamide : 0.088% max
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Prednisolone

Character:White to practically white crystalline powder IdentificationA: by IRB: by UV, absorptivities differ 2.5%max.Specific rotation: +97+103oLoss on drying:(Anhydrous) 1.0% max Residue on ignition : Negligible from 100mgSelenium : 0.003% maxChromatographic PurityIndividual impurity: 1.0%max. Number of impurities above 0.5%: 1max.Total impurities: 2.0%max.Assay (on the dried basis): 97.0102.0%Residual solventsMethanol : 1000ppm max. Dichloromethane : 600 ppm max
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Estrone

Character :white crystals or white to creamy white crystalline powder Identification : A, IR B, UV Specific rotation :+158 +165o Clarity of solution :Meet the requirement Residue on ignition : 0.5% max. Loss on drying : 0.5% max.Ordinary impurities:Total impurities 2.0%max.Limit of equilenin & equilin :2.0% max.Residual Solvents: Methanol: 3000ppm max Ethanol:5000ppm max Acetone:5000ppm max Chloroform: 60ppm max Assay (on dried basis):97.0% to 103.0 %
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Racepinephrine HCl

Appearance : Fine, white, odorless powder; Darkens on exposure to light and air Identification (A, UV; B, Cl- test ): conforms Specific rotation : -1o to +1oWater : 0.5% max.Residue on ignition : 0.5% maxResidual Solvents : Meets the requirements Limit of adrenalone : 0.2 max.Limit of norepinephrine* : 4.0% maxAssay (on anhydrous basis): 97.0-102.0%Residual solvents Isopropanol: 5000ppm maxAcetone: 5000ppm maxEthanol: 5000ppm max
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Epinephrine Bitartrate

Appearance:White or grayish white or light brownish gray, odorless, crystalline powder Identification:-50 to -53.5 o Melting range:147 152oC, with decomposition Loss on drying: 0.5% max . Residue on ignition:Negligible, from 100mg Limit of Adrenalone: Absorptivity @310nm: 0.2 max. Limit of Norepinephrine bitartrate : 4.0%max. Assay(on the dried basis) : 97.0-102.0% Residual solvents : Ethanol: 0.5%max. Methanol : 3000ppm max
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Resveratrol

Assay (on dried basis): 98.0% minAppearance: White to off white powder Odor : Characteristic Sulfated ash: 3.0%maxMoisture: 5.0%maxHeavy metals:
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Estradiol Valerate

Appearance:white crystalline powderIdentification:Complies by IR Melting range:143oC to 150oC. Specific rotation:41o to +47o. Water:0.1 max. Limit of estradiol : 1.0% max.Free acid :0.5% max. Ordinary Impurities:Total: 2.0 max.Assay:98.0 to 102.0
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  • Wilson Jiao (Syntec Pharma Corp)
  • 96 Gazza Blvd., Farmingdale, NY 11735, USA, New York
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