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
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
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
sifter in last purification additionally, which would yield a
clarified and transparent
injection with the same dosage.
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
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