How To Import Quetiapine Fumarate API From China? (Step-By-Step Procedure)

There are plenty of Quetiapine Fumarate Manufacturers in China. And the key is to choose the most suitable one.

The key to finding your perfect supplier is choosing one that offers top quality and reasonable prices.

Firstly: GMP-Approved Manufacturers with HIGH QUALITY

If you are a pharmaceutical manufacturer, your API supplier should have a GMP certificate issued by the Chinese NMPA.

On that basis, they should also have GMP certificates issued by other official authorities, such as the USFDA and EU, 

That means the raw material you are importing is not only produced strictly in accordance with cGMP guidelines but also approved by CEP, COS, USFDA, and WC. Thus, it is suitable for producing finished dosages for compounding pharmacies or pharmaceutical dosage manufacturers.

Certificates will be proof of high quality.

Not 100% correct, though.

You need to check its quality using those three testing items.

1.1)  Content control of impurities:

As we all know, the higher the purity of an ingredient, the better, and it is true to some degree.

However, only professionals know that controlling impurities matters.

In many cases, impurity content is more important than the actual purity value, reflecting a certain degree of optimization in your manufacturing process.

The USP requires less than 0.15% for known impurities and less than 0.1% for unknown single impurities. It is tough.

If you review our testing results for those impurities in the Certificate of Analysis below, you will find that OCTAGONCHEM’s impurity control is exceptionally high.

COA Of Quetiapine Fumarate from OCTAGONCHEM

The number of known impurities is not more than 0.01%, and the number of unknown impurities is 0.008%, for a total of 0.05%.

Now you see what our so-called high quality means.

1.2) Low residual solvent content:

We typically use four solvents to synthesize and purify quetiapine: methanol, ethanol, toluene, and N, N -diethylaniline.

The results show that neither methanol nor N, N-diethylaniline is present in our quetiapine, and the ethanol and toluene contents are 0.07% and 0.006%, respectively.

Low levels of toluene and residual solvents also reflect the optimization of our synthesis process, of which we are proud.

1.3) Testing results of residue on ignition/loss on drying

The value of Loss on Drying reflects the content of volatile matter, such as water and solvents.

Our loss on drying test results are only 0.09%, well below the requirement of 0.5%.

Residue of ignition is an indicator of inorganic content in the API; the smaller, the better.

If the value is small, there is a low content of organic matter

Our ignition residue test result is 0.03%, which is significantly lower than the USP requirement of NMT 0.1%.

From the three points above, you can see that the quality of our quetiapine fumarate is exceptionally high.

If you are still unsure, request a sample to test our quality.