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How to easily distinguish between the specification and the reference product
We know that the reference substance refers to the standardized substances used in the national drug specifications for identification, content determination, and related substance inspections, etc., and is an important component and special measuring device that cannot be used in short, and is the fundamental standard for measuring the quality of drugs in research and production; Of course, the reference product is also the material specification of the proofreading test equipment and methods. The regulatory product is the agent of the Research Center of Standards for Traditional Chinese Medicine Standards. It is used as a measurement standard and used as a drug. It is the normative content of the content determination. Regulatory products include stoichiometric specifications, metallurgical specifications, and drug testing specifications.
Difference between regulatory products and reference products
Controls refer to the normative substances used to identify, view, determine and verify the function of the instrument, and normatives refers to the normative substances used in biological assays, determination of the content or potency of antibiotics or biological drugs, in potency units (U). show. In the literature, two kinds of concepts are often mixed, and the reference substance is the regulatory product. It is a reference to two kinds of substances. The cause of the mistakes may be that some drugs contain both reference and regulatory products.
Regulatory products are normative substances used in bioassays, antibiotics, or biopharmaceuticals that are measured in potency units (U). National regulatory products and biological reference products refer to the standardized substances used for identification, examination of content or potency determination, and their preparation and calibration shall be in accordance with the requirements of the “Regulations for Preparation and Calibration of National Standards for Biological Products†and shall be designated by the State Drug Administration. Distribute the organization. It is necessary for the company's work regulations or reference products to be made after national regulatory products or reference standards.
Specifications and reference materials are accompanied by operating instructions, quality requirements, expiration date and quantity. Biological product specification material means the biological specification product or biological reference material used for the determination of the titer, activity or content of a biological product, or the identification and inspection of its characteristics.
Regulatory products mixed with reference products
The use of reference or regulatory products in combination with reference or regulatory products is not a method of determining the contents of the calibration method. It is a problem that often appears in the drug inspection but does not attract attention. Although there is a good correlation between the contents of different calibration methods in the same batch of control products, they are not exactly the same, and sometimes they are very different. For example, the cefuroxime ester reference product supplied by Glaxo, UK was calibrated with HPLC as 96.9% for content determination and UV as 98.8% for dissolution determination. Despite the clear rules in our country's Pharmacopoeia, the reference standards issued by the Ministry of Health are only used for the analysis methods that are regulated in the text.
Regulatory products and reference materials
The regulatory products are now available in China's National Institute for the Control of Pharmaceutical and Biological Products. There are 2,930 species of various kinds of national regulatory substances available, 650 kinds of Chinese medicine chemical reference materials, and 730 kinds of reference medicines. There are 1,243 kinds of national regulatory substances available for reference products, 288 kinds of chemical reference materials for traditional Chinese medicines, and 400 kinds of reference medicines, accounting for more than half of the total.