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Apremilast 608141-41-9 Apremilast 608141-41-9

Apremilast 608141-41-9
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Basic information of Apremilast

Name

Apremilast

Alias

Apremilast (CC-10004)

CAS NO.

608141-41-9

Molecular Formula

C22H24N2O7S

Molecular Weight

460.51

Quality Standard

99% min

Grade Standard

Medicine grade

Package Size

1kg packing

Use of Apremilast

Apremilast was approved by the USFDA in March 2014 for treatment of adults with active psoriatic arthritis. Apremilast is the first oral agent that is FDA-approved for the treatment of psoriatic arthritis and offers the convenience of oral dosing compared to treatment with biopharmaceuticals. In September 2014, the USFDA approved Otezla (apremilast) for the treatment of moderate to severe plaque psoriasis.It is also being tested for its efficacy in treating other chronic inflammatory diseases such as ankylosing spondylitis, Behcet's disease, and rheumatoid arthritis.

COA of Apremilast

Items

Specifications

Results

Appearance

Off-white to white powder

Off-white powder

Related Substances

Any single unknown impurity≤0.1%

Total impurities:≤0.5%

0.09%

0.13%

Enantiomer

<0.5%

0.12%

Loss on drying

Not more than 0.5%

0.03%

Melting Point

154~158℃

155.6~156.7℃

Residue on ignition

Not more than 0.5%

0.01%

Residual solvents

Methanol <3000ppm

Ethanol <5000ppm

THF<720ppm

Acetonitrile<410ppm

Acetone <5000ppm

Dichloromethane <600ppm

560ppm

N.D.

N.D.

66ppm

800ppm

N.D.

Purity(HPLC)

≥99%

99.87%

Results

The product conforms to the above specifications.


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MORE_DETAIL Apremilast 608141-41-9

Basic information of Apremilast

Name

Apremilast

Alias

Apremilast (CC-10004)

CAS NO.

608141-41-9

Molecular Formula

C22H24N2O7S

Molecular Weight

460.51

Quality Standard

99% min

Grade Standard

Medicine grade

Package Size

1kg packing

Use of Apremilast

Apremilast was approved by the USFDA in March 2014 for treatment of adults with active psoriatic arthritis. Apremilast is the first oral agent that is FDA-approved for the treatment of psoriatic arthritis and offers the convenience of oral dosing compared to treatment with biopharmaceuticals. In September 2014, the USFDA approved Otezla (apremilast) for the treatment of moderate to severe plaque psoriasis.It is also being tested for its efficacy in treating other chronic inflammatory diseases such as ankylosing spondylitis, Behcet's disease, and rheumatoid arthritis.

COA of Apremilast

Items

Specifications

Results

Appearance

Off-white to white powder

Off-white powder

Related Substances

Any single unknown impurity≤0.1%

Total impurities:≤0.5%

0.09%

0.13%

Enantiomer

<0.5%

0.12%

Loss on drying

Not more than 0.5%

0.03%

Melting Point

154~158℃

155.6~156.7℃

Residue on ignition

Not more than 0.5%

0.01%

Residual solvents

Methanol <3000ppm

Ethanol <5000ppm

THF<720ppm

Acetonitrile<410ppm

Acetone <5000ppm

Dichloromethane <600ppm

560ppm

N.D.

N.D.

66ppm

800ppm

N.D.

Purity(HPLC)

≥99%

99.87%

Results

The product conforms to the above specifications.

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