Application of Hach Lab Turbidity Meter in Quality Inspection of Pharmaceutical Industry

Hash turbidity meter has always had an excellent reputation in the field of wastewater treatment and discharge in the pharmaceutical industry. Especially on July 1, 2010, the full enforcement of the "Water Discharge Standards for the Pharmaceutical Industry" will bring more application opportunities to this sector.

However, when paying attention to the sewage treatment of pharmaceutical factories, please do not ignore the application of Hach products in the quality inspection department of pharmaceutical factories. The following hash product series can be used in the pharmaceutical factory quality inspection department

Turbidity meter series, such as 2100N

Colorimeter series, such as lico500

Electrochemical series, such as HQd series

Potentiometric titrator series, such as TIM8XX series

Spectrophotometer / colorimeter series, such as DR6000

KF moisture analyzer, such as TIM580 / 585

This time talk in detail about the application of Hach Lab turbidity meter in the pharmaceutical industry quality inspection:

The Chinese Pharmacopoeia requires that most bulk drugs and lyophilized preparations should meet the corresponding clarification standards for quality inspection. Freeze-dried products will also increase the quality inspection standards for visible foreign objects and insoluble particles.

Clarity is to check the degree of turbidity of the drug solution, that is, turbidity. If there are fine particles in the drug solution, when direct light passes through the solution, light scattering and light absorption phenomena may occur, causing the solution to be slightly cloudy; therefore, the clarity reflects the drug quality and production process level to a certain extent.

The clarification test method prescribed in the Chinese Pharmacopoeia is the visual turbidimetry method:

Pharmacopoeia stipulated method-visual turbidimetric method: Clarity is determined after turbidity with turbidity standard solution. Standard number: WS1-F03-89

This method is to place a certain concentration of test solution and turbidity standard solution in paired turbidity glass tubes (inner diameter: 15-16mm, flat bottom, with plug, made of colorless, transparent, neutral hard glass In), the height of the liquid surface is 40mm, 5 minutes after the preparation of the turbidity standard solution, on the same black background, under the diffuse light, observe and compare from the top of the turbidity tube downward; or place it vertically in the umbrella shed light Under, the illuminance is 1,000lx, observe and compare from the horizontal direction; used to check the clarity or turbidity of the solution.

When the clarity of the test product solution is the same as the solvent used, or does not exceed the No. 0.5 turbidity standard solution, it is a clear solution.

[Preparation of Turbidity Standard Stock Solution

Weigh 1.00g of hydrazine sulfate, put it in a 100ml measuring flask, add appropriate amount of water to dissolve it, if necessary, dissolve warmly in a 40 ° C water bath, and dilute with water to the mark, shake well, and place for 4 to 6 hours Mix equal volume of 10% urotropine solution, shake well, and let it stand at 25 ° C in the dark for 24 hours. This solution can be used within two months in a cool place away from light. Shake well before use.

【Preparation of Turbidity Standard Stock Solution】

Take 15.0ml of the turbidity standard stock solution, place it in a 1,000ml measuring flask, dilute with water to the mark, shake well, and you get it. This solution should be used within 24 hours, shake well before use. Preparation of turbidity standard solution The turbidity standard stock solution is prepared according to the following table. This solution should be prepared immediately before use and shake well before use.

However, in the EU Pharmacopoeia, in addition to the visual method for clarification, there is also the instrument method. That is measured with a turbidity meter. The EU Pharmacopoeia also clearly stated that the instrument method can more accurately and conveniently measure the clarity, because the measurement will no longer be affected by the visual acuity of the tester, and the convenient multiple measurement results are more conducive to quality and process control. Especially in the stability check, the instrument method is highly recommended.

In addition, the hash turbidity meter has a unique advantage in the determination of clarity. Using the adapter LZV783 and LYY621 (or LCW902) sample cell, the Hach Turbidity Meter can achieve a unique 2ml sample on the market to determine the clarity.

In addition, it has been found that some pharmaceutical factories use a photometer to replace the visual method, that is, the absorbance of the sample solution and the prepared standard turbidity liquid are measured at a certain wavelength. It is estimated by using a colorimeter or a spectrophotometer to measure the attenuation of the transmitted light intensity caused by the obstruction of particles in the sample. But this is an application misunderstanding:

First, it does not meet the definition of turbidity: turbidity is measured with an instrument called a turbidimeter. The turbidity meter emits light, passing it through a section of sample, and detects how much light is scattered by particles in the water from a direction 90 ° from the incident light. This method of measuring scattered light is called the scattering method. Any true turbidity must be measured this way.

Measurement using light transmittance is susceptible to interference such as color absorption or particulate matter absorption. Moreover, there is no correlation between the light transmittance and the results measured by scattered light measurement. Nonetheless, at certain times the measurement results of colorimeters and spectrophotometers can be used to measure large changes in turbidity in water treatment systems or process control.

In short, using a turbidity meter instead of visual turbidimetry or photometry to determine clarity is more accurate and convenient. Second, it does not need to consider the difference in visual acuity of the tester. Third, it conforms to the definition of turbidity. In the Pharmacopoeia, it must be said that this will be a trend of determination.

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