Paclitaxel API quality introduction

 Paclitaxel API produced by Guilin Huiang Biochemistry Pharmaceutical Co., Ltd. has a higher quality standard as Huiang internal control standard comparing national standard of China and USP. There are many analysis items following would illuminate it.

 1.      Assay.

Huiang lists Assay specification as 99.5%~102.0% in its internal control standard, beyond lower limits of national standard 98.0%~102.0% and USP 97.0%~102.0%. Product with higher assay means lower impurities within, which would be controlled by impurity content and impurity quantity.

 In impurity content, including single and total content, are strictly controlled by Huiang, especially 7-epi-paclitaxel is not more than 0.08% which decrease its harm on human being. And the total content of impurity is identified less than 0.5%, better than 2.0%, the USP limit. On the other respect, huiang paclitaxel contains single impuritie count less than 7. Comparing the standards of 13 and 10 of national standard and USP, that is to say, huiang paclitaxel has less side-effect and more stability.

 High assay Paclitaxel with low impurity is also a strong protector for injection manufacturer. Commonly, for manufacturing paclitaxel injection or other formulation, paclitaxel API would be dissolved by solvent media, and then pass through 0.45μ and 0.2μ sifters in succession. In order to minimize microbe, huiang use a 0.45μ sifter in last purification additionally, which would yield a more clarified and transparent injection with the same dosage.

 2.      Organic solvent residue and water.

The internal standard illustrates much better parameter on organic solvent residue than that of national standard and USP, the difference would range up to 1/40. Water upper limit, 0.6% in internal standard VS 4.0% in USP is another way to explain the strictly quality controlling of Huiang.

 We regard that organic solvent residue and water would affect product stability directly. Many stability tests and data show that product from Huiang has high stability after strongly control on these two items. In 2006 and 2007, SFDA approved Huiang paclitaxel natural and semi-synthesis the expiry extending from 18 months to 36 months respectively, the longest expiry for paclitaxel API in China.

 It is known widely that organic solvent residue harm on human health, ICH also developed and regulated guidance to restrict using in process of pharmaceutical ingredients. In Chinese pharmacopeia 2005, some regulates are built according to the international guidance. Huiang’s manufacture is restricted by these guidance and regulations to ensure the safety of product usage.

 3.      Microbe and bacterial endotoxins.

Mmicrobe and bacterial endotoxins analysis are normally not necessary for paclitaxel API in Chinese pharmacopeia. Aiming at provide excellent product with top quality, Huiang carries these items in routine analysis, as USP required. Thought it would increase 10 times analysis cost than before, Huaing insist product sell domestic or abroad to passing these analysis.

 From COAs of every batch product, we can see the parameters almost keep at the same level, which illustrate that only an advanced and stable process, perfect analysis method and skill can create top quality.

 Thanks to focusing on quality, Huiang was designated by regulatory parties as monography developer and reference standard provider of paclitaxel for Chinese pharmacopeia 2010. It can demonstrate huiang product is officially recognized.

 Beside product quality, Huiang also attaches attention to after-sales service. During using of paclitaxel API, if contamination or damage occurs by accident, Huiang will provide remediation or related service in time. Also technical support is provided on analysis procedure, if necessary.

Huiang hope more people would get knowledge of us; we also hope we could start the business with more clients and seek for a common development.