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Shandong Loncom Pharmaceutical Co.Ltd.
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1.Atomoxetine hydrochloride is the hydrochloride form of atomoxetine, a drug used for the nervous system, and belongs to an adrenergic transmitter reuptake inhibitor, used to treat inattention and hyperactivity. Tomoxetine is a selective norepinephrine reuptake inhibitor (SNRI) whose structure is similar to fluoxetine.
2.Atomoxetine hydrochloride is the first stimulant drug approved by the to treat attention deficit disorder with hyperactivity (ADHD). It has not been found in clinical trials to cause other stimulant drugs or cause euphoria drugs. . Randomized, placebo-controlled trials in children and adults have confirmed that the product can effectively treat ADHD. |
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Sinoway Industrial Co. Ltd
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Product name
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Atomoxetine hydrochloride; Atomoxetine HCL
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Alias
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Benzenepropanamine,N-methyl-g-(2-methylphenoxy)-,hydrochloride, (R)-;Benzenepropanamine, N-methyl-g-(2-methylphenoxy)-, hydrochloride, (gR)- (9CI);
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CAS No.
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82248-59-7
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Molecular Formula
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C17H22ClNO
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Molecular Weight
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291.821
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Molecular Structure
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Quality Standard
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99% up by HPLC
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Appearance
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White crystalline powder
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ANALYSIS
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SPECIFICATION
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RESULTS
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Appearance
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Off-white or white powder
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Conforms
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Solubility
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It is easy to soluble in absolute ethanol, slightly soluble in water, and almost insoluble in heptane.
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Conforms
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Melting point
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166。C ~ 169。C
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167.5。C-168。C
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Specific rotation
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-34.0。~ -38。
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Conforms
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Identification
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Retention time of the main peak of the test product and the main peak of the reference product are the same
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Conforms
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The infrared light absorption spectrum should be consistent with the reference spectrum.
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Conforms
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Identification of chlorides in aqueous solution of this product
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Positive
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Related substances
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O-cresol≤0.10%
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Conforms
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Amphetamine≤0.10%
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N.D.
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Phenylpropanolamine≤0.10%
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N.D.
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Dimethy tomoxetine≤0.10%
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N.D.
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Desmethoxetine≤0.3%
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0.03%
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The single impurity≤0.10%
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0.04%
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The total impurities≤0.50%
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0.14%
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Enantiomer
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≤0.15%
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0.001%
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M-tomoxetine
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≤0.10%
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N.D.
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P-tomoxetine
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≤0.10%
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N.D.
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Residual solvents
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Methanol≤0.30%
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0.18%
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Dichloromethane≤0.06%
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N.D.
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N-hexane≤0.029%
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N.D.
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Ethyl acetate≤0.50%
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N.D.
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Cyclohexane≤0.388%
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N.D.
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Toluene≤0.089%
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N.D.
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Loss on drying
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≤0.50%
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0.09%
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Residue on ignition
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≤0.10%
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0.04%
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Heavy metal
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≤10ppm
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Conforms
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Assay(drying)
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98.0% - 102.0%
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99.5%
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Conclusion
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The product meets enterprise standard.
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What is Atomoxetine hydrochloride?
Atomoxetine hydrochloride (Atomoxetine HCL) is a medication that is primarily used to treat attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. Atomoxetine hydrochloride belongs to a class of drugs known as selective norepinephrine reuptake inhibitors (SNRIs). Unlike other medications used to treat ADHD, such as stimulants like amphetamines, atomoxetine does not belong to the stimulant class. Instead, it works by increasing the levels of norepinephrine, a neurotransmitter involved in regulating attention, in the brain. By affecting the balance of neurotransmitters, atomoxetine helps to improve attention, reduce impulsivity, and decrease hyperactivity in individuals with ADHD. It is believed to have a longer-lasting effect than stimulant medications and does not carry the risk of abuse or dependence.
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Pharma Sources Insight January 2025
