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Simple method for determination of content of sodium caprylate in human albumin through GC method

A technology of human serum albumin and sodium octanoate, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of sodium octanoate toxicity, etc., and achieve the effects of short operation time, increased experimental efficiency, and small operation deviation

Inactive Publication Date: 2016-08-10
LIAONING CHENGDA BIOTECH
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Problems solved by technology

However, sodium octanoate has certain toxicity, and its content in human albumin needs to be controlled

Method used

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  • Simple method for determination of content of sodium caprylate in human albumin through GC method
  • Simple method for determination of content of sodium caprylate in human albumin through GC method
  • Simple method for determination of content of sodium caprylate in human albumin through GC method

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Embodiment Construction

[0049] The content of the invention will be described in detail below through examples, which are not intended to limit the invention.

[0050] 1. Sampling order:

[0051] Blank solution (1 needle)

[0052] Internal standard solution (1 needle)

[0053] Standard solution (6 needles)

[0054] Linear solution (1 needle each)

[0055] Limit of quantitation solution (6 needles)

[0056] Precision solution (1 needle each)

[0057] Accuracy solution (1 needle each)

[0058] Sampling sequence after flow rate change (±25%): standard solution (6 needles).

[0059] 2. System suitability verification.

[0060] Purpose: To confirm that the chromatographic conditions meet the system suitability requirements and can meet the detection needs.

[0061] Method: 6 needles of standard solution were used to verify the system applicability, and the resolution of octanoic acid peak and heptanoic acid peak, the area ratio of octanoic acid peak to heptanoic acid peak, RSD value, and the tail...

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Abstract

The invention discloses a simple method for determination of the content of sodium caprylate in human albumin through a GC method, and is characterized in that during use of trichloromethane to prepare a sample, the method is simple, and system suitability, specificity, quantitation limit, linearity, accuracy, precision and durability are in line with the 'Chinese Pharmacopoeia' drug quality standard analytical method validation guiding principles and requirements of 'guidance of GMP for drug.quality control laboratories and materials management'. A conventional method for determination of the content of sodium caprylate in the human albumin through a gas chromatographic method is improved, and the improved method is subjected to verification of system applicability, accuracy, precision, specificity, quantitation limit, linearity and durability, ensures that the analytical method can meet the measurement requirements, and has the advantages that trichloromethane has no need for dry volatilization, the operation time is short, the efficiency of experiments is increased, the organic phase volume is 1.0 mL and operation deviation is small.

Description

Technical field [0001] The present invention relates to a method for measuring biological products, in particular to a simple GC method for measuring the content of sodium octanoate in human albumin. The invention uses gas chromatography to detect the content of sodium octanoate in human albumin, and optimizes Detection methods were developed and new methods were verified. Background technique [0002] Sodium caprylate is widely used as a stabilizer for human albumin. It can stabilize and protect human albumin during the heating and insulation process, prevent albumin from denaturing, and ensure a good appearance of the product. However, sodium octanoate has certain toxicity, and its content in human albumin needs to be controlled. "Chinese Pharmacopoeia" stipulates that every 1g of protein should be 0.140~0.180mmol. [0003] The "Chinese Pharmacopoeia" has included the sodium octanoate determination method (Appendix VI K), but this method requires sample preparation to ev...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/025
Inventor 杨健
Owner LIAONING CHENGDA BIOTECH
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