99% up, USP34，GMP, DMF Paclitaxel 33069-62-4

Name: 99% up, USP34，GMP, DMF Paclitaxel 33069-62-4
Availability: 99-up-usp34-gmp-dmf-paclitaxel-33069-62-273816.html

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:99% up, USP34，GMP, DMF Paclitaxel 33069-62-4
CAS No.:33069-62-4
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co. Ltd

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Product Information

Product name	Paclitaxel
CAS No.	33069-62-4
Molecular Formula	C47H51NO14
Molecular Weight	853.92
Quality Standard	99% up, Medicine Grade
Appearance	White crystalline powder

COA of Paclitaxel

Appearance	White or almost white crystalline powder
Identification	FT-IR
	HPLC
	NMR
	Mass
Solubility	Soluble in ethanol, methanol, Chloroform, hardly soluble in water
Specific Optical Rotation	-49.0º ~ -55.0º at 20°C
Melting Point	213°C—216°C
Water	≤1.0%
Residual Solvent	Meets the requirements of ICH
Ethyl Acetate	≤5000ppm
Acetone	≤5000ppm
Methanol	≤3000ppm
Acetic acid	≤5000ppm
Residual of volatile Solvents	Meets the requirements of ICH
Chloroform	≤60ppm
Dichloromethane	≤600ppm
Hexane	≤290ppm
Toluene	≤890ppm
Residue on Ignition	≤0.2%
Bacteria endotoxins	≤0.4 USP EU/mg
Total aerobic microbial count	≤100 cfu/g
Staphylococcus aureus	Absence
Pseudomonas aeruginosa	Absence
Salmonella species	Absence
Escherichia Coli	Absence
Heavy Metals	≤20 ppm
IMPURITIES:
10-Deacetyl Baccatin III	≤0.1%
Baccatin III	≤0.2%
Photodegradant	≤0.1%
10-Deacetyl Paclitaxel	≤0.5%
2-Debenzoylpaclitaxel-2-pentenoate	≤0.7%
Oxetane ring opened, Acetyl and benzoyl	≤0.1%
10-Acetoacetyl paclitaxel	≤0.1%
10-Deacetyl-7-epi-paclitaxel	≤0.3%
	≤0.4%
7-epi-paclitaxel	≤0.4%
10,13-Bissidechainpaclitaxel	≤0.5%
7-Acetyl Paclitaxel	≤0.6%

Usage

Paclitaxel powder is a chemotherapy drug that is given as a treatment for some types of cancer. Paclitaxel powder is a mitotic inhibitor now used to treat patients with lung, ovarian, breast cancer, head and neck cancer, and advanced forms of Kaposi's sarcoma. Paclitaxel is also used for the prevention of restenosis.

Function of Paclitaxel
1. Paclitaxel is a mitotic inhibitor drup used in the treatment of cancer.
2. Isolated the compound from the bark of the Pacific yew tree, Taxus brevifolia, and noted its antitumor activity in a broad range of rodent tumors.
3. Paclitaxel has since become an effective tool of doctors who treat patients with lung, ovarian, breast cancer, and advanced forms of Kaposi's sarcoma.

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99% up, USP34，GMP, DMF Paclitaxel 33069-62-4

Product Information

Product name

Paclitaxel

CAS No.

33069-62-4

Molecular Formula

C47H51NO14

Molecular Weight

853.92

Quality Standard

99% up, Medicine Grade

Appearance

White crystalline powder

COA of Paclitaxel

Appearance

White or almost white crystalline powder

Identification

FT-IR

HPLC

NMR

Mass

Solubility

Soluble in ethanol, methanol, Chloroform, hardly soluble in water

Specific Optical Rotation

-49.0º ~ -55.0º at 20°C

Melting Point

213°C­—216°C

Water

≤1.0%

Residual Solvent

Meets the requirements of ICH

Ethyl Acetate

≤5000ppm

Acetone

≤5000ppm

Methanol

≤3000ppm

Acetic acid

≤5000ppm

Residual of volatile Solvents

Meets the requirements of ICH

Chloroform

≤60ppm

Dichloromethane

≤600ppm

Hexane

≤290ppm

Toluene

≤890ppm

Residue on Ignition

≤0.2%

Bacteria endotoxins

≤0.4 USP EU/mg

Total aerobic microbial count

≤100 cfu/g

Staphylococcus aureus

Absence

Pseudomonas aeruginosa

Absence

Salmonella species

Absence

Escherichia Coli

Absence

Heavy Metals

≤20 ppm

IMPURITIES:

10-Deacetyl Baccatin III

≤0.1%

Baccatin III

≤0.2%

Photodegradant

≤0.1%

10-Deacetyl Paclitaxel

≤0.5%

2-Debenzoylpaclitaxel-2-pentenoate

≤0.7%

Oxetane ring opened, Acetyl and benzoyl

≤0.1%

10-Acetoacetyl paclitaxel

213°C—216°C

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