As early as 1975, it was proposed to perform insoluble particle inspection on a large volume of single-dose liquid. After filtering with a filter, the particle size was measured and counted with a microscope and a micrometer, and the number of particles larger than 10 μm and 25 μm per 1 mL was calculated. . Later, the United States Pharmacopoeia gradually expanded the scope of application of insoluble microparticles, including large-volume multi-dose preparations, small-volume single-dose preparations, and even water-insoluble preparations, powder injection preparations, and the like. The PLD-601A Pharmacopoeia insoluble particle tester is used in most pharmacopoeias.
Until the United States Pharmacopoeia published in 1995, the photoresist method was added to the original microscopy method. Because of its high degree of intelligence and wide application range, it has a very good development prospect. The US Pharmacopoeia put this method on The first place. Due to the relative nature of instrumental analysis and the complexity of instrument calibration, the US Pharmacopoeia also clearly specifies that samples that fail to pass the photoresist test should be retested using a microscope. The final judgment should be based on the results of the microscopy method. quasi.
[British Pharmacopoeia]
The method of insoluble particle inspection was also collected very early. It was first seen in the 1973 edition of the Pharmacopoeia using microscopy. It is required to have a particle control project for infusions above 500 mL. There are less than 1000 particles per ≥2 μm of liquid, and less than 100 particles of ≥5 μm. One.
It was not until 1980 that the resistance method was included, and that an instrument such as the resistance method could not solve the problem, it could also be inspected using a photoresist method. However, in the newly published British Pharmacopoeia in 1998, this inspection has undergone tremendous changes. The resistance method has been replaced by the photoresist method for nearly 25 years. The photoresist method has become the inspection method of the new British Pharmacopoeia, exemplifying the PULUODY pharmacopoeia insolubility. The particle inspection instrument belongs to the photoresist method.
ã€Japanese Pharmacopoeia】
It was first seen in the 1980 edition of the Pharmacopoeia, using microscopy, until the 1995 edition of the Pharmacopoeia introduced the photoresist method as the first choice, the method and limits are the same as the United States Pharmacopoeia, and the results of the inspection of the conditions complying with the photoresist method can be arbitrated. Microscopy is used for partial and small-dose injections (less than 25 mL) that cannot be detected by photoresist.
[European Community Pharmacopoeia]
With the construction of European integration, the reasons for harmonization and reunification are the same as those of the British and American Pharmacopoeias.
Chinese Pharmacopoeia monitoring of particulate contamination in injections:
[Chinese Pharmacopoeia] From 1985 to 1995, the insoluble particles in the injection were examined by microscopy. Check ≥10μm and ≥25μm, which is basically the same as the US Pharmacopoeia standard.
In the 2000 edition of the Chinese Pharmacopoeia, the second method, the photoresist method, was added to the insoluble particles in the injection.
In the 2005 edition of the Chinese Pharmacopoeia, the detection of small dose injections was added.
[Chinese Pharmacopoeia] The first draft of the 2005 edition revised the monitoring of insoluble particulate contamination in the injection, and revised the photoresist method to the first method, and the microscope method to the second method. The revised results are also consistent with the United States, Britain, the European Community, and Japan.
Pharmacopoeia insoluble particle inspection instrument introduction:
The Pharmacopoeia insoluble particle tester can monitor and analyze liquid particle size, cleanliness, and contaminants; pharmaceutical equipment and its routine maintenance and maintenance; wear test in pharmaceutical parts; insoluble particles in pure solution and ultrapure water; Cleanliness test of packaging materials; monitoring of attached particles of human bones; detection of insoluble particles in pharmacopoeia;
The Pharmacopoeia insoluble particle inspection instrument adopts the core technology of Proud in the United Kingdom - "resistance measurement particle", and can be built according to the requirements of users.
The precision piston pump and ultra-precision flow electromagnetic control system are adopted to realize the double control with constant injection speed and accurate injection volume. The sampling amount is 1ml~ infinitely set freely and accurately.
The sensor uses Proud's classic "resistance measuring particle" sensor, which is more suitable for more than 510 international standards based on this principle.
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