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 FINASTERIDE

SYNONYMS:

1,(5a)-androstan-4-aza-3one-17beta@
N-tert-butylcarboxamide)

 

 

CAS NO.:

98319-26-7    

 

EINECS NO.:

200-278-5

 

FORMULA:

C23H36N2O2

 

H.S. CODE:

3004.9036

 

CLASS NO.:

N/A

 

UN NO.:

N/A

 

NFPA:

2-1-0

 

DESCRIPTION:

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.

 

APPLICATION

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.

SPECIFICATION & PACKING

Description      White or almost white

crystalline powder

Identification      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 total (HPLC base on drying)  98.5%~101.0%
Packing:1KG/TIN

Storage: Finasteride should be stored at room temperature in a tight light
resistant container.

RAW MATERIAL:

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

END GOODS:

N/A

REMARKS:

N/A

MATERIAL SAFE DATA SHEETS

1. Identification of Substance and of Manufacturer
Product Name: Finasteride
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(¡Á) Inhalation(¡Á) Ingestion(¡Á)
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.

 

CERTIFICATE OF ANALYSIS

 

Product

:

Finasteride

Date of COA

:

JUN.13,2006

Mfg. date

:

2006-1-8

Exp. Date

:

2009-1-7

Batch No.

:

060101

 

 

 

 




ITEM

RESULTS

ODD DETERMINANT

Description

White or almost white crystalline powder

white crystalline powder

Identification

Complies with the standard

complies

Specific rotation

-56.0~-60.0

-58.5

Loss on drying

max. 0.3%

0.14%

Residue on ignition

max. 0.1%

0.06%

Heavy Metals

max. 10ppm

complies

Relative materials

max. 0.5%

0.3%

(HPLC)

total 1.0%

0.6%

Assay total

(HPLC base on drying)

98.5%~101.0%

99.40%





























 


Conciusion: The test product compies with the requirements of USP28 Standard