|
Product Name:
|
Duloxetine
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CAS:
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116539-59-4
|
EINECS:
|
1533716-785-6
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MF :
|
C18H19NOS
|
MW:
|
297.41
|
Grade Standard :
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Pharmaceutical Grade
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Assay:
|
99%HPLC
|
Appearance:
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White Powder
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Packaging:
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Aluminum Bag
|
Sample:
|
Available
|
Storage:
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Stored in a cool & dry place
Kept away from strong light and heat
|
Shelf Life:
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2 years when properly stored
|
Duloxetine is used to treat depression and anxiety. In addition, duloxetine is used to help relieve nerve pain (peripheral
neuropathy) in people with diabetes or ongoing pain due to medical conditions such as arthritis, chronic back pain, or
fibromyalgia (a condition that causes widespread pain).
COA of Duloxetine Powder
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Product Name
|
Duloxetine powder
|
|
Other Name
|
Duloxetine HCL
|
|
Batch Number
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TGY20180719
|
|
Batch Quantity
|
1000KG
|
|
Manufacture Date
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2018-07-19
|
|
Expiration Date
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2020-07-19
|
|
Item
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Specification
|
Result
|
|
Assay
|
99%
|
Conforms
|
|
Organoleptic
|
|
Appearance
|
White Powder
|
Conforms
|
|
Odor
|
Characteristic
|
Conforms
|
|
Physical Characteristics
|
|
Partial size
|
100% Through 80 Mesh
|
Conforms
|
|
Loss on Drying
|
≤5%
|
4.5%
|
|
Heavy Metals
|
|
Total Heavy Metals
|
≤10ppm
|
Conforms
|
|
Arsenic
|
≤2ppm
|
Conforms
|
|
Hg
|
≤2ppm
|
Conforms
|
|
Pesticides
|
≤2ppm
|
Complied
|
|
Microbiological Tests
|
|
Total Plate Count
|
≤1000cfu/g
|
Conforms
|
|
Total Yeast & Mold
|
≤100cfu/g
|
Conforms
|
|
Yeast&Mold
|
≤100cfu/g
|
Conforms
|
|
Salmonella
|
Negative
|
Negative
|
|
E.Coli.
|
Negative
|
Negative
|
Conclusion
|
Conform to EP8.0
|
Duloxetine is a selective serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor. Preclinical studies have
shown that duloxetine is a strong inhibitor of neuronal 5-HT and NE reuptake, and the inhibitory effect on
dopamine reuptake is relatively weak. In vitro studies have shown that duloxetine has no significant affinity for
dopaminergic receptors, adrenergic receptors, cholinergic receptors, histamine receptors, receptors, glutamate
receptors, and GABA receptors. Duloxetine does not inhibit monoamine oxidase
1. For the treatment of severe depression, can effectively treat depression and emotional and physical symptoms
2. For diabetic peripheral neuropathic pain.
3. For women with moderate to severe stress urinary incontinence.
