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Product Categories
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- High performance liquid chromatography 3Q validation
- Efficient leak detection
- Device 3Q verification
Zeheng Metrology Testing (Hubei) Co., Ltd
High performance liquid chromatography 3Q validation
NegotiableUpdate on 12/17
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Overview
The 3Q validation of high-performance liquid chromatography is to confirm that the related facilities and equipment of the liquid chromatography can comply with the standards and requirements of the "Good Manufacturing Practice for Drugs" and JJG 700-2016 "Verification Regulations for Liquid Chromatography", and to confirm that the liquid chromatography can be used normally within the predetermined limits and allowable range according to the design, and that the performance of each part can be effectively repeated, maintaining stability and reliability continuously, and meeting the requirements of the enterprise's use; And develop effective preventive measures for potential risks.
Product Details
High performance liquid chromatography 3Q validation
1. Purpose:
High performance liquid chromatography (hereinafter referred to as the instrument) is an analytical instrument composed of an infusion system, an injection system, a separation system, a detection system, and a data processing system. Liquid chromatography is used to separate samples based on the differences in distribution or adsorption characteristics between the stationary and mobile phases of each component in the chromatographic column. The mobile phase is used to introduce the sample into the chromatographic column for separation, and the chromatogram is detected by a detector and recorded by a data processing system. Qualitative and quantitative analysis is performed based on the retention time and response values (peak area or peak height) of each component.
2. Verification purpose
forConfirmed that the facilities and equipment related to the liquid chromatography instrument can comply with the standards and requirements of the "Good Manufacturing Practice for Drugs" and JJG 700-2016 "Verification Regulations for Liquid Chromatography Instruments", and confirmed that the liquid chromatography instrument can be used normally within the predetermined limits and allowable range according to the design, and the performance of each part can be effectively repeated, maintaining stability and reliability continuously, and meeting the requirements of the enterprise's use; And develop effective preventive measures for potential risks.
VerifiedHigh performance liquid chromatographyIdentify potential deviations in the operation or use of facilities and equipment that do not meet requirements, as well as unreasonable system parameter settings, and make adjustments and corrections to ensure that the operation of relevant facilities, equipment, and systems meets the specified requirements and standards.
By verifying the relevant facilities and equipment of high-performance liquid chromatography, effective preventive measures can be developed for potential risks that may affect the normal use of the enterprise.
That's allHigh performance liquid chromatography 3Q validationThe purpose. About moreYou can leave a message about the relevant knowledge of high-performance liquid chromatography.
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