Service Background

Residual solvents in pharmaceuticals refer to the organic solvents used in the production of APIs or excipients, as well as in the preparation of preparations, but not completely removed in the process. Unless otherwise specified, the residual limits of the first, second and third types of solvents should be in accordance with the provisions of the Pharmacopoeia; for other solvents, the corresponding limits should be formulated according to the characteristics of the production process so as to make them comply with the product specifications, Good Manufacturing Practice (GMP) or other basic quality requirements.

Analysis of Drug Solvent Residues

According to the 2020 edition of the Chinese Pharmacopoeia “0861 Residual Solvent Determination Method” general rules, the detection of residual solvents in pharmaceutical products is divided into four categories, involving 70 solvents.
1. Solvent residue analysis: Qualitative and quantitative analysis of organic solvents in samples using advanced chromatographic techniques. In addition to Pharmacopoeia, we can also select appropriate testing methods and conditions according to industry standards or customer-specific requirements.
2. method development and validation: customize specific solvent residue detection methods for customers, and carry out strict validation, provide a full set of parameter reports for method validation.
3. Technical support and consulting: provide professional technical consulting services to help customers solve problems encountered in the control and management of solvent residues; according to the latest regulations and standards changes, provide customers with timely updates and training.

Service Purpose

Solvent residue testing is an important part of pharmaceutical quality control, and its purpose is to ensure that the residues of organic solvents used in the manufacturing process of pharmaceutical products do not exceed the specified safety limits in the final product. These organic solvents may originate from the manufacturing process of APIs or excipients, as well as from the preparation of formulations. Detection and control of solvent residues is essential as organic solvents may pose potential risks to patient health.

Service Recipients

1. API manufacturers;
2. pharmaceutical manufacturing enterprises;
3. pharmaceutical research institutes, etc.

Our Advantages

1. Professional technical team: we have experienced analytical scientists and professional technicians who are capable of handling complex samples and testing needs.
2. advanced equipment: using the latest chromatography and detection equipment to ensure the accuracy and reproducibility of data.
3. Strict quality control: We follow dual quality management systems (FDA and CNAS) to ensure the reliability of the testing process and results.
4. Customized service: Provide personalized service solutions according to customers' specific needs, including the selection and optimization of detection methods.