南宫NG28

◉Service Introduction

Biological enzyme catalytic reactions have the advantages of high specificity, mild conditions, and green environmental protection, and are increasingly widely used in the production process of APIs. The International Enzyme Commission (I.E.C) divides enzymes into 6 major categories according to the type of reaction catalyzed by the enzyme - transferases, hydrolases, lyases, oxidoreductases, isomerases and ligases. The enzyme catalyst used to prepare APIs is a process impurity and its residue needs to be controlled.

Protein residue
The methods for determining protein content include Kjeldahl method, Folin phenol method (Lowry method), biuret method, BCA method and Coomassie brilliant blue method (Bradford method). Among them, Coomassie brilliant blue method is favored because of its highest sensitivity and low interference. This method can determine the amount of protein of 1~200ug.

DNA residues
CTI uses fluorescent staining to detect the residues of fermentation microbial DNA in raw materials.

Sugar residues
Whether it is starch, polysaccharides or oligosaccharides, the sugars can be converted into monosaccharides by hydrolysis, and the sugar residues can be detected by HPLC-CAD method.

◉Service Background

Recently, CDE has also paid attention to the residues of enzymes, starch, DNA, etc. in the catalytic reaction when conducting new drug reviews for APIs synthesized by enzymes. CTI Pharma and Medical Services has established an analytical method for the residues of three components (DNA, protein, and sugar).

◉ Applicable products

Applicable to APIs prepared by enzyme catalysis or fermentation. Such as Vildagliptin, Demeclocycline hydrochloride, Atorvastatin calcium, Erythromycin, etc.

◉ Service content

Residue testing and method verification of three components (DNA, protein, sugar) in APIs.
According to the ChP 2020 Vol Ⅳ“9101 Guidelines for Validation of Analytical Method Adopted in Pharmaceutical Quality Specification” ,require for analytical methods and verification performance indicators, CTI performs method validation according to the requirements of the impurity quantitative analysis method.. The parameters examined include specificity, linearity/range, accuracy, precision (repeatability/intermediate precision), detection limit and quantification limit, and solution stability.
The sensitivity of the method can meet most application scenarios.

◉ Special services

For APIs that are easily soluble in water, the sample volume required for a single method test is only 2~3g, and 20~30g of sample is required for method development and validation.

◉ Service Process