Responding to the new requirements of the 2010 Chinese Pharmacopoeia on the monitoring of water quality in pharmaceutical water

October 09, 2020

Responding to the new requirements of the 2010 Chinese Pharmacopoeia on the monitoring of water quality in pharmaceutical water
                    ——Solution of pure water, water for injection and sterile water for injection in pH, conductivity and total organic carbon determination

Applications:

● Biopharmaceuticals, chemical medicines, pharmaceutical raw materials, etc. require precise measurement of pH, conductivity, and total organic carbon (TOC) for pure water, water for injection, and sterile water for injection.

Program background:

In 2010, the Chinese Pharmacopoeia proposed the following requirements for the detection of pH, conductivity, and total organic carbon (TOC) of pure water, water for injection, and sterile water for injection:
1 New requirements for pH detection in the Pharmacopoeia: The pH should be between 5.0 and 7.0.
2 Pharmacopoeia new requirements for conductivity detection: adjust the temperature of the sample to be tested to 25 °C. When the labeling amount is 10 ml or less, the conductivity limit is 25 μS/cm; when the labeling amount is 10 ml or more, the conductivity limit is 5 μS/cm. If the measured conductivity value is not greater than the limit value, it is judged to be in compliance with the regulations; if the conductivity value is greater than the limit value, it is judged to be non-compliant.
3 New requirements for total organic carbon (TOC) in the Pharmacopoeia: Total organic carbon (TOC) values ​​should be less than 0.5 μg/mL.
1. The total organic carbon (TOC) measurement technique should be able to distinguish between inorganic carbon (carbon dioxide produced by the decomposition of carbon dioxide and bicarbonate dissolved in water) and organic carbon (carbon dioxide produced by oxidation of organic matter), and can exclude inorganic carbon to organic Interference in carbon determination.
2. The requirements of the system suitability test should be met.
3, should have sufficient detection sensitivity (the minimum detection limit is equal to or less than 0.05mg / L per liter of carbon).


Supporting plan:


According to the requirements of the 2010 Chinese Pharmacopoeia, Shanghai Qunmai Laboratory Equipment Co., Ltd. provides the following solutions.

According to the new requirements of the pharmacopoeia for pH detection, the configuration should be:
● US CLEAN PH5000 pH/ORP controller + US SNEX CS1668U /CS1768U pH composite electrode
+ US CLEAN CPB401BT / CPB700BT NIST traceable pH standard solution .

    According to the new requirements of the pharmacopoeia for conductivity detection, the configuration should be:
● US CLEAN CON5000 Conductivity / Resistivity / TDS Controller + US CLEAN Titanium Alloy Conductive Electrode
(K=0.01)+ US CLEAN CCON5BT NIST traceable conductivity standard solution .

  According to the new requirements of the Pharmacopoeia for total organic carbon (TOC) testing, the configuration should be:
● UK PPM PROTOC 100TL total organic carbon TOC online analyzer .

Program advantages:
The above solutions are required: accurate measurement, satisfying demand, convenient configuration, high cost performance and low maintenance.


Related Links:

US CLEAN PH5000 pH/ORP Controller US CLEAN CON5000 Conductivity / Resistivity / TDS Controller UK PPM PROTOC 100TL Total Organic Carbon TOC Online Analyzer

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