Paclitaxel

F.W. : 853.93

Assay (HPLC) : > 99.5%

IR Spectrum : Identical to Standard.

MASS Spectrum : Identical to Standard.

NMR Spectrum : Identical to Standard.

UV Spectrum (0.002% methanol solution) : Maximum absorption at 227 (^+/_2) nm..

Specific Rotation : 49^O (^+/_ 0.5).

Melting Point : 213 - 217^OC (with decomposition).

Moisture (K.F.) : < 1.5%

Impurities (7-epi-10-deacetyl taxol) (HPLC) : < 0.5%.

Total Impurities (HPLC) : < 0.5%

Residue on Ignition (USP 23 method) : < 0.2%

Heavy Metals (USP 23 method II) : < 20 ppm

Chlorides : < 0.1%

Description : White microcrystalline powder.

Solubility : Practically incoluble in water. Easily soluble in methanol, chloroform and ethyl ether.

CERTIFICATE OF ANALYSIS

NAME OF PRODUCT: PACLITAXEL                    BATCH NO.: 991229

REPORT DATE: DEC 29,1999                           QUANTITY:  SAMPLE

Paclitaxel may be one of the most important anticancer agents to be developed over the pasttwo decades. With its unique mechanism of action as an inducer of tubulin assembly,paclitaxel has demonstrated impressive antitumor activity in patients with breast, lung (both non-small cell and small cell), head and neck, and advanced and platinum-refractory ovarian carcinomas.

Paclitaxel's antitumor activity was discovered in the 1960s during a largescale 35,000 plants-screening program sponsored by the National Cancer Institute (NCI), USA.

In 1983, NCI began conducting clinical trials of paclitaxel's safety and its effectiveness against various types of cancer. Demand for paclitaxel increased in 1989 after the investigators at The Johns Hopkins Oncology Center reported that the drug produced partial or complete responses (shrinking or disappearance of the tumor) in 30 percent of previously treatedpatients with advanced ovarian cancer. it was clear that ovarian cancer patients with few otheroptions benefited from the treatment.
 
 

In December 1992, FDA approved the use of paclitaxel for refractory (treatment-resistant) ovarian cancer Subsequently, clinical trials using paclitaxel for the treatment of advanced breast cancer demonstrated that the drug is effective against this disease.

In April 1994, FDA approved the use of paclitaxel for breast cancer that has recurred within 6 months after the completion of initial chemotherapy and for metastatic breast cancer that is not responding to combination chemotherapy.

March 1997, FDA designated TaxolÒ (Paclitaxel Injection) as Orphan Drug for treatment of AIDS-related Kaposi's sarcoma.

April 1998, FDA gave an additional approval for Paclitaxel injections, for first-line therapy for the treatment of advanced carcinoma of the ovary in combination with cisplatin.

June 1998, Bristol-Myers Squibs Company (BMS) received an NDA 20-262/S-024 for a TaxolÒ indication: in combination with cisplatin, for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy
 Researchers continue to look for new and better ways to use paclitaxel in the treatment of cancer. They are studying paclitaxel's effectiveness when used to treat breast and ovarian cancer earlier in the course of these diseases and when used in combination with other drugs. Trials to test the effectiveness of paclitaxel against many other types of cancer, including leukemia, lymphoma, and cancers of the lung, head and neck, and colon, also are in progress. In addition, researchers are investigating ways to overcome some patients' resistance to paclitaxel and are trying to develop methods for using the drug in patients who have impaired organ function

To date, 180 clinical trials have been conducted, researchers have found the drug to be active in lung, head and neck, bladder, esophageal, and germ cell cancers.

Packaged in a vacuum, water-repellent, anti-microbial, aluminum bag. Storage: Store in original package between 2° and 25°C (36° to 77°F). Retain in a container to protect from light.

As demand for paclitaxel increased, researchers have been exploring new resources to increase the availability of paclitaxel.

BMS produces Paxlitaxel Injection (TaxolÒ ) via a semi-synthesis process from Taxus baccata (Europe Yew).

There have been many research reports on the constitutions of othet yew tree species worldwide.

Scientists in US, China, Japan, Taiwan and other countries have done detailed research on Taxus chinensisi (Chinese yew) as the new resource of paclitaxel. There are four Chinese yew species growing on the territory of China. Scientists proved that all of them contain paclitaxel at a similar level as the Taxus brevifolia. Scientists have isolated and identified 110 taxanes from Chinese yews, and 36 of them were new taxanes. in vitro and in vivo studies proved that paclitaxel has the strongest anti-cancer activity.

Chinese pharmaceutical enterprises in cooperate with Chinese academic institutions developed a new production line to extract pure paclitaxel from planted 3-5 years young Taxus chinensis. With the large field of planted young Taxus chinensis, which contains paclitaxel as high as 0.015 - 0.02%, and the new manufacturing technology, China's Natural Paclitaxel has become the  most reliable new resource of high quality natural paclitaxel with very competitive cost.

Clinical trials in China since 1995 have proved the effectuveness and safety of Natural Paclitaxel Injection (which contains paclitaxel extracted from Taxus chinensis) in cancer treatment.

The pure natural paclitaxel is ideal for the paharmaceutical manufacturers and research laboratories to use for developing new anti-cancer preparations,and new taxane derivatives

     We really need to get feed back from our customers in order to improve our performances.
Any information about quotations from competitors will be welcomed since we hope to work as a team with you.
Your kind help will be very much appreciated.

     Best regards from SHENZHEN , China

                                                       Mr. JEFFERY TSUI

If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning and redness. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, some throat and nausea have been reported.

This product is for pharmaceutical manufacturers and research laboratories use only. It is not for the direct clinical administration.