南宫NG28

Service Background

Elemental impurity analysis is an important part of pharmaceutical quality control, and the International Coordination Committee for the Registration of Pharmaceuticals for Human Use (ICH) has issued a number of guidelines to standardize and guide the study and control of elemental impurities in pharmaceuticals.
Among them, ICH Q3D(R2) provides detailed methods for analyzing and evaluating elemental impurities in pharmaceutical products, and safety assessment principles.Since ICH Q3D came into effect, the industry has been paying more attention to the detection of trace elements in products. Elemental impurities do not have a positive effect on patient care and therefore need to be controlled to an acceptable level, i.e. below the PDE value.

Analysis of elemental impurities in raw and auxiliary drugs and finished products

Applicable products
Applicable to APIs, excipients, finished drugs, etc.

Service
Evaluate the types of elements to be tested based on the route of administration, the classification of the element, and whether it is artificially added. Calculate the limits of the elements in the product in combination with the dosage of the finished drug product and the PDE of the element. Analytical method development and validation using ICP-MS/OES.

Specialty Services

• Scanning or quantitative analysis of 24 elements specified in ICH Q3D.
• Elemental impurity analysis using ICP-MS/OES in accordance with each country's pharmacopoeia.

Service Objects
This product serves many industries and fields, and the following are representative customer targets:
1. pharmaceutical manufacturing companies;
2. biopharmaceutical companies;
3. pharmaceutical R&D laboratories, etc.