General Test Services by BOC Sciences
                     BOC Sciences’ pharmaceutical separation and purification team are 
committed to the  separation and identification of various impurities in the 
process of pharmaceutical  research. Our experts are highly recognized by 
customers with their rich experience  and problem-solving skills.
Our Conventional Services for Impurity Isolation 
 and Identification
Impurity control is one of the core contents of drug quality control, and 
impurity  research runs through the whole process of drug research and 
development. The  isolation and identification of drug impurities are the 
most direct means for the study of  impurities, and the separated impurities 
can be used for an in-depth study of qualitative,  quantitative and safety. 
BOC Sciences provides comprehensive impurity identification.
 Impurities - Quantitative
To achieve quantitative analysis of impurities, we can separate 
impurities to obtain  single components of impurities with good purity. 
We can add additional tests for  impurities, including residual solvent 
(GC) and water content (Karl Fischer).
BOC Sciences’ Unique Technology
Liquid chromatography is widely used in downstream process crossing 
several  industries. The technology becomes standard separation process 
to remove impurities  or undesirable chemicals. Normally, the products are 
separated by affinity or  hydrophobicity interaction with chosen functional 
columns. However, the state-of-art  approach is limited in large 
biomolecules separation because of the lack of control in  pore size. In 
fact, although size exclusion separation provides higher resolution, the  
technique is seldom used in the processing step because of the high 
pressure needed.
In addition to the conventional impurity isolation and identification 
techniques, we  provide an alternative method to remove small molecular 
impurities below six  angstrom with 100 times larger throughput. The 
technology is developed based on  patented materials possess well-
defined six angstrom porosity to identify products  from impurities. 
Moreover, the chromatography column is further designed to achieve  100 
times better throughput.
The patented materials are self-assembled, highly symmetrical, 
ultrasmall inorganic  cages directed by surfactant micelles, developed by 
research team at Cornell  University.
This new technology can be used for removal of precursor or small 
molecular  impurities under 6 angstrom, such as carcinogens, degradation 
products and other  unknown impurities. Our initial proof-of-concept 
experiment has successfully  demonstrated the viability of the technology 
for the separation of small molecule  impurities that have recently led to 
recalls due to the unacceptable level of NDMA  contaminations in the high-
blood pressure drug, Ibesartan.
Note:
NDMA has attracted wide attention as being highly hepatotoxic and a 
known  carcinogen in lab animals. High levels of exposure can cause 
reduced function of the  kidneys and lungs. To date, NDMA has caused 
several recalls and warnings of  successful drugs on the market, including 
Valsartan, Losartan, Irbesartan, Ranitidine  and Metformin.
The experiment results show that the genotoxic impurity, NDMA in drug 
products was  removed more than 99% (from 2000 ppm to < 1 ppm) by 
our new technology and the  concentration went down below FDA’s daily 
allowance intake. At the same time, the  yield of active pharmaceutical 
ingredient retained more than 90%. The measurements  were conducted 
by following FDA published GC methods. Lower concentration can be  
achieved by repeating the separation process.