Impurity Analysis & Control

The sources of impurities in preparations mainly include the introduction of raw materials, formulation process or degradation during the storage, etc. Alfa Chemistry provides complete analysis services for a series of potential impurities including organic impurities, isomers, genotoxic impurities, residual solvents, and elemental impurities in the product.

Figure 1. Classification of pharmaceutical impurities. (Kung-Tie, L.; Chien-Hsin, C. 2019)

Alfa Chemistry's Solutions

• Consistency evaluation of oral solid preparations

Focus of impurity analysis: impurities produced by degradation and impurities introduced by the preparation process.

Analysis strategy: literature search, analysis of raw material characteristic, forced degradation test and other methods to support the comparative analysis of impurity profiles.

• Consistency evaluation of injection

Focus of impurity analysis: pyrogen (bacterial endotoxin) introduced during the production process, eachables and elemental impurities.

Control strategy: microbial control or sterility assurance strategy.

Our Services

Alfa Chemistry provides the analytical results of identification of impurity source, analysis reports, and impurity control strategies combined with the comprehensive research on the degradation pathway of the APIs, the compatibility testing of the API, excipients, and packaging materials.

Impurity Analysis Services

• Analysis of organic impurity
• Identification of isomer: isomer impurities produced by degradation, isomer impurities present in the drugs with more than one chiral center
• Analysis of genotoxic impurity: genotoxic impurities introduced by APIs, genotoxic impurities produced by degradation process
• Analysis of residual solvent
• Analysis of mutagenic impurities
• Elemental impurity analysis: elemental impurities can be introduced from raw materials and production equipment. We provide ICP-MS detection services for the efficient and accurate analysis of elemental impurities
• Analysis of heavy metals and toxic metals: lithium, vanadium, chromium, cobalt, nickel, copper, arsenic, selenium, molybdenum, cadmium, barium, platinum, lead and more than ten kinds of heavy metals

Impurity Control Services

• Simplify the control procedures for low-risk known impurities based on conducting sufficient risk assessment
• Assess the feasibility of process control, the feasibility of controlling a single unknown impurity, or the feasibility of reducing the use of reference substances by introducing correction factors
• Identify known impurities by applying the high-accuracy reference substance method

Impurity Control Workflow

Step 1 Investigation of the RLD: Identify impurities in your generic drug and the detection method

Step 2 Preliminary test: Confirm the detection ability and separation ability of the detection method

Step 3 Method validation: Comparison with the impurity profile of the RLD

Figure 2. Comparison of the application scopes of regulatory guidelines/guidance for the management of impurities in pharmaceutical products. (Kung-Tie, L.; Chien-Hsin, C. 2019)

Our Advantages

• An experienced assay team with accumulated rich technical experience in the fields of process analysis, organic component analysis, inorganic component analysis, etc.
• Alfa Chemistry's state-of-the-art laboratory with strict quality control system has passed the qualification certification, and can provide comprehensive testing solutions according to customer needs
• Our experts provide a suitable detection scheme based on the characteristics of the drug and content of the element to be tested