Quality ~


Our Commitment

At Binowe, our mission is to provide the purest, most stable, and highest quality reference materials for the global scientific research, medical, and health industries as well as the field of life sciences. All our raw materials are pharmaceutical grade, with a purity of no less than 99%. We strictly enforce quality standards and inspect each new batch of raw materials to ensure strict compliance with standards.


Raw Material Source and Quality Assurance

We not only pay attention to the source of organic raw materials but also attach great importance to the quality and stability of each batch of products. All our raw materials come from suppliers who can provide the highest quality, ensuring no fillers, binders, adjuvants, dyes, or any impurities. At the same time, we are the only supplier certified by the Institution of Chemical Engineers (IChemE) for third-party purity verification by analytical chemists.


Independent Testing and Authoritative Certification

Since the autumn of 2019, we have started testing from three independent laboratories. In addition, we have also conducted blind independent tests, confirming the authenticity and dosage of our products. We use the most advanced quality control methods to ensure that our products are always in the best active state. We actively cooperate with third-party laboratories for random sampling and independent verification. All formulations have undergone further independent testing in multiple occasions through regulatory investigations with the UK regulatory authorities in the MPS laboratory; MHRA (Medicines and Healthcare Products Regulatory Agency) cooperates with the MET police team. These are globally recognized authoritative institutions. Our product quality and reliability have set new standards in the industry.


Advanced Production Process and Purity Determination Method

Traditionally, chemical purity is determined using HPLC and UV detection. However, using HPLC alone may lack sensitivity and specificity, leading to structural ambiguity. Today, the best method for performing mass spectrometry quantification is to use a mass spectrometer that can perform MS/MS fragmentation, which is usually completed by a triple quadrupole or ion trap mass spectrometer.


The Importance of MS/MS and Our Method

The reason for needing MS/MS is that many compounds have the same complete mass. Although many researchers use the first dimension of MS for quantification, this technology again lacks specificity. In most cases, the second dimension of MS fragments resolves any ambiguity. The combination of specific parent mass and unique fragment ions is used to accurately explain, annotate, and quantify the purity of almost any compound. Unfortunately, for academic and R&D field research scientists, most manufacturers (including many large multinational chemical companies) limit their analysis to HPLC-UV to save time and money for quality control. This is very unprofessional.

By utilizing a new generation of mass spectrometry analysis, we can enhance our purity assessment by increasing sensitivity and adding new measurement dimensions. Undoubtedly, our LC/MS-MS method provides better quality assurance and control than the traditional HPLC-UV method. This is particularly important for analysis, where many exist in the form of non-chiral mixtures. The quantitative resolution of these mixtures requires highly sensitive instruments, such as our triple quadrupole spectrometer.


Purity Assessment Involving LC/MS:

  • Determine the purity of the sample by measuring the peak area percentage of the target component.
  • Confirm the identity of the target component through MS by using isotope patterns, molecular ions, and adduct ions.
  • Confirm peak purity using 3D UV and MS data.
  • Method development, data collection/processing, and report generation are all performed using fully licensed comprehensive chromatography system software to meet regulatory data integrity requirements.


Our Equipment and Strict Quality Inspection

Our production process utilizes industry-leading high-performance liquid chromatography and liquid/gas chromatography-mass spectrometry technology, as well as analysis routinely performed in clinical laboratory environments. We use a range of flexible Thermo Scientific and Agilent equipment for these analyses: 3D ion trap liquid chromatography-mass spectrometry, triple quadrupole gas chromatography-mass spectrometry, linear ion trap liquid chromatography-mass spectrometry, electrospray and atmospheric pressure chemical ion sources, ultraviolet detectors, and nano-flow liquid chromatography. Each batch of products undergoes strict quality inspection during the production process and is subject to comprehensive mass spectrometry/mass spectrometry analysis to resolve any potential ambiguity. Each batch of products is carefully prepared and tested by our medical laboratory to ensure compliance with the claims on the label.


Our Goal

Binowe’s policy is: Only by providing high-quality, safe, and reliable top-quality materials can we truly support the global scientific research, medical, and health industries. Our goal is to ensure that customers fully trust our products through continuous scientific optimization.