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| Description
of Finasteride |
Formula
of Finasteride: C23H36N2O2
F.W. of Finasteride: 372.54
CAS no. of Finasteride: 98319-26-7
DOT of Finasteride: Nill
NFPA no. of Finasteride:
Class no.of Finasteride: Nill
UN no. of Finasteride: Nill
HS code of Finasteride: 3004.9036
Specific Gravity of Finasteride: Nill
Chemical Name:N-tert-butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide
Finasteride is a white crystalline powder with a melting point near
250degree C. It is freely soluble in chloroform and in lower alcohol solvents,
but is practically insoluble in water. Finasteride tablets for oral
administration are film-coated tablets that contain 5 mg of finasteride
and the following inactive ingredients: hydrous lactose, microcrystalline
cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl
cellulose LF, hydroxypropyl methylcellulose,titanium dioxide, magnesium
stearate, talc, docusate sodium, FD&C Blue 2 aluminum lake and
yellow iron oxide. |
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| Specification
of Finasteride |
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FINASTERIDE
USP28
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| Items |
Specification |
| Description: |
White
or almost white crystalline powder |
| Identification:
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Complies
with the standard |
| Specific
rotation: |
-56.0~-60.0 |
| Loss
on drying: |
max.
0.3% |
| Residue
on ignition: |
max.
0.1% |
| Heavy
Metals: |
max.
10ppm |
| Relative
materials: |
max.
0.5% |
| (HPLC):
|
total
1.0% |
| Assay
(HPLC base on drying): |
98.5%~101.0% |
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| Application
of Finasteride |
|
Finasteride
is used in chemoprevention of prostate cancer,used in cosmetic
industry for Hair loss drug.
Finasteride is used to treat symptoms of BPH. Finasteride is approved
for use with the alpha-blocker, doxazosin, to reduce the progression
of symptoms of BPH.
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| Packing&Storage
of Finasteride |
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Packing
of Finasteride: 1kg/Tin
Storage of Finasteride: Finasteride should be stored at room temperature
in a tight light resistant container.
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| MSDS
of Finasteride |
Material
Safety Data Sheets of Finasteride
1. Identification of Substance and of Manufacturer
Product Name: Finasteride
Manufactune's Name: Ronas Chemicals Ind. Co., Ltd.
For emergency or information's on health hazards call:0086 28-86082869
2. Data on substance
Product Name : Finasteride Code number:
Chemical name: 1,(5a)-androstan-4-aza-3one-17beta@N-tert-butylcarboxamide)
CAS number: 98319-26-7 EINECS number: Chemical family: Steroids
Therapeutic category:
Fromula: C23H36N2O2 Molecular weight:372.54
3. Hazard Identification
Hazard designation: Xn (Harmful)
Threshold limit value(TLV): Not established
Routes of absorption: Dermal(×) Inhalation(×) Ingestion(×)
Effcet of over exposure:
4. Emergenc/and First Aid Procedure
Remove from exposure. Remove contaminated clothing. Persons developing
serious
Hypersensitivity reactions must receive Immediate medical attention.
Remove the fresh air.
Inhalatior: May cause irritation of respiratory tract. Avoid Inhalation.
Remove to fresh air.
Eyes: May cause irritation. Flush with copious quantities of water.
Skin: May cause irritation. Flush with copious quantities of water.
Ingestion: May cause irritation. Flush out mouth with water.
5. Fire and Explosion Hazard Data
Extinguishing media: Water spray, dry chemicals, carbon dioxide
or foam as appropriate for surrounding fire and materials.
Special
fire fighting procedures: Evacuate personnel to safe area. Fire-fighters
should use self-contained equipment and protective clothing.
Unusual
fire and explosion hazards: Combustible. Ground mechaincal equipment
to dissipate potential static electricity build-ur. Emits acrid
and toxic fumes under fire condition.
6 Spill or Leak Procedures
Steps to be taken if material is released or spilled: Water suitable
to protective clothing, approved respirator and rubber gloves.
Vacuum or sweep up spillage.
Avoid dus : Place spillage in appropriate container for waste
disposal. Wash contaminated clothing before reuse. Ventilate area
and wash spill site.
Waste disposal method: Disposse off waste in accordance with applicable
national and local laws regarding disposal of medicinal waste.
7. Handing and storage.
Precaution to be taken in handing and storing: Store at room Temperature
in tight container with protection from light and humidity.
Other pregautions: Avoid contact with eyes, skin or clothing.
Avoid breathing dust or mist. Use with adequate dust control.
Wash thoroughly after handing.
8. Special Protection Information's
Respiratory protection: NIOSH approved respirator.
Ventilation: Adequate Local exhaust: Recommended
Mechaincal: Recommended
Protective gloves: Rubber or PVC eye protection: Safety goggles
Other protective equipment: Appropriate laboratory apparel, protect
exposed skin.
9 Physical and Chemical Data
Appearance and odour: White or almost white crystalline powder,
odorless
Biolling point: N.A. Melting point:251253degree C
Vapour density: N.A. Vapour pressure: N.A.
Evaporatior rate: N.A. Flash Point: N.A.
Flammable limits: N.A. Auto-ignition Temperature: N.A.
Reactivity in water: N.A. PH: N.A.
Solubility: Partially insoluble in water; very soluble in dichloro
methane; freely soluble in acetone; soluble in methanol; sparingly
soluble in ethanol.
Note: N.A.: Not applicable
10 Reactivity and Stability Data
Stability stable Incompatibility(material to avoid): Strong oxidant
Condition to avoid: Material is stable from a safety point of
view.
Hazardous decomposition products: When heated to decomposition
it emits acrid smoke and fumes.
Hazardous polymerisation: Will not occur.
11 Toxicological Information's
Toxicity data:
12.Ecologlcal Information's
No data is available regarding risks to waterways. Avoid that
the product Id discharged Into waterways or drains which can contaminate
groundwater.
Product Name: Finasteride Code number:
13. Considerations Regarding Disposal
Do not dispose of product together with domestic waste; Do not
discharge into sewer. Dispose of by incineration.
Contaminated packing material: Dispose of in accordance with local
regulations.
14. Information Regarding Transport
ADR/RID Transport by roadl/rall: No restrictions
LCAO/IATA Air transport: No restrictions
15. Regulatory Information
Classification according to EC Dircetive:
Symbol: Xn(Harmful)
Risks?
R20/21/22 Harmful by Inhalation , in contact with skin and if
swallowed.
R36/37/38 Irritating to eyes, respiratory system and skin.
Safety recommendations (S)
S22 Do not breathe dust
S24/25 Avoid contact with skin and eyes.
16. Other information
This material safety Date Sheet was prepared in accordance with
EEC Directive 93/112 of Dec.10,1999 and is intended to assist
the recipient in complying with own obligations. The data contained
in this documents was that available at the time of its preparation
and was compiled from the following sources: Merck Index, Martindale-The
Extra Pharmacopoeia, Sax. This information is intended for safety
purposes only when the product id uses for pharmaceutical purposes
and is not a guarantee of the product characteristics.
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| Finasteride raw
mateiral |
| 1)
Ammonia,anhydrous,4-androsten-3-one-17b-carboxylic acid,tert-butylamine,n,n-dicyclohexylcarbodiimide,hydrogen,1-hydroxy-1,2,3-benzotriazole,phenylseleninic
anhydride,platinum,potassium permanganate,sodium carbonate,sodium
periodate |
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| Finasteride end
goods |
| Drugs
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Substitute
of Finasteride |
| Nill |
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| Importing
& exporting rules of Finasteride
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| Normal
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