Analysis, Testing, and Quality Research

Analysis, Testing, and Quality Research

Analysis and Testing

Quality Studies

As a professional oligonucleotide product synthesis and service unit, Biosyntech has complete equipment, instruments, and a professional technical team. Based on the current version of the Chinese Pharmacopoeia, USP/EP/BP and other relevant regulations, policies, and enterprise methods in the pharmaceutical industry, Chinese Pharmacopoeia can provide customized method development and in-depth research, quality standard establishment, revision, and review, drug stability research and investigation, as well as impurity analysis, to help enterprises quickly and smoothly pass new drug application and approval.

● Methodology development and validation

Methodological validation is an evaluation of the determination method, as well as a methodological evaluation of the revision, validation, and replication of existing methods. Methodological validation includes but is not limited to verifying the specificity, system applicability, quantification limit, detection limit, linearity and range, precision, accuracy, durability, etc. of the method to demonstrate its compliance with relevant requirements.

● Establishment, revision, and review of quality standards

Assist enterprises in establishing quality standards based on the key characteristics of drugs and relevant quality control points, in order to effectively monitor the safety and effectiveness of drugs.

● Research and investigation on drug stability

The study and investigation of drug stability is an important link in ensuring the quality, safety, and effectiveness of drugs. By simulating the laws of drug changes over time under various environmental factors such as temperature, humidity, and light, it provides scientific basis for the production, packaging, storage, and transportation conditions of drugs, and determines the expiration date of drugs.

● Impurity analysis

Using advanced analytical instruments such as LC/MS/MS to effectively detect toxic and elemental impurities in formulations and raw materials, providing solutions for drug impurity research.