Quality Control - Kohn & Shawn Pharmatech

Quality Control

In the process of development has been to product quality management as the first priority, has gradually established and improve the quality management system, the company has obtained ISO9001:2015 quality system certification. And in the development of continuous increase in analytical instruments, equipment purchase and personnel training and other aspects of investment to improve detection technology, improve detection indicators. Each batch of products we send is accompanied by a detailed quality inspection list, including: batch number, product characteristics, purity, production date, shelf life, storage conditions, analytical data and other detailed data. It can also provide analytical inspection conditions and assist in the transfer of analytical methods when required by customers. There is a complete quality file storage system, which can realize the efficient traceability of the corresponding test data and other quality files of each batch of products.

Product quality control is achieved in the following ways

Complete raw material inspection procedures + supplier qualification and evaluation + raw material COA + raw material MOA (each batch of raw material information can be traced)

Intermediate quality inspection (quality standard + inspection procedure data can be traced)

Product quality testing (quality standard + inspection procedure data can be traced)

Each batch of product analysis and inspection certificate (COA) and detection map can be traced

Keep samples for at least one year for each batch of products

Product stability test, mass customized products can provide product stability test data

It can complete the transfer of raw materials, intermediates and product methods

Storage of quality documents related to each batch of products (file cabinet)

Technology and means for quality control

Mass Spectrometry
Chromatographic Technique
Spectral technique
Metal content analysis
Polarimetry
Melting point, moisture test
titration

Mass spectrometry

Through the effective use of liquid chromatography-mass spectrometry technology and gas chromatography-mass spectrometry technology has established about 80% of the company's products MS spectrum library, combined with nuclear magnetic detection can effectively achieve compound identification.

Chromatographic technology

Equipped with a number of domestic and foreign mainstream brands of high-performance liquid chromatographs and gas chromatographs, to meet the supplier's raw material inspection, production line and R & D sample detection, and can cooperate with customers to achieve a series of work such as analytical method development and transfer.

Spectral technology

Spectral technology is a qualitative and quantitative analysis method based on the absorption, reflection and emission of light by matter. By studying and analyzing the spectral characteristics of substances, this technique can provide information about the composition, structure and content of substances

Metal content analysis

Metal composition analysis is a test method used to determine the chemical composition of metal materials. It includes qualitative and quantitative analysis to determine the amount of each component in the metal. Analytical methods include chemical analysis, instrumental analysis and physical methods. Specific application areas include stainless steel, ordinary steel, copper alloy, zinc alloy, aluminum alloy, nickel alloy, magnesium alloy, solder and other metal material testing.

Polarimetry

Photometry is a method of measuring a drug or checking the pure impurity of a drug by using the optical rotation that occurs when a plane polarized light passes through a liquid or solution containing certain optically active substances (such as compounds with asymmetric carbon atoms). Mainly used for: drug identification, impurity inspection and content determination.

Melting point, moisture test

The melting point test and the moisture test are two different physical test methods used to determine the specific properties of a substance.
The melting point test is a commonly used physical test method to determine the temperature at which a substance melts under a specific pressure and environment
A moisture test is a physical test method used to determine the amount of moisture in a substance.

Titration

Equipped with titrator, titration work can be more simple and efficient. Equipped with medicine cool cabinet to realize the classification and storage of various standard products.