The medium and reagents should meet the quality control standards. When using commercially available media and reagents in the laboratory, the manufacturer's information should be retained and the acceptance procedure should be established. If verification is required, it can be performed according to the laboratory's test method for the quality control of commercial media and reagents. Meet the requirements of the appendix quality control standards.
Test strains are a set of strains that have stable characteristics of their representative species and are effective in demonstrating the best performance of a laboratory-specific medium. The test strains are mainly purchased in the standard strain collection center, or they can be isolated strains of the laboratory with good characteristics. The laboratory should detect and record the characteristics of standard stock strains; or select new strains with typical characteristics that should be used with care; it is best to use strains isolated from food or water.
For the medium without indicator or selection agent, only one positive strain should be used for testing; for the medium or reagent containing indicator or selection agent, the strain which can prove its indication or selection should be tested; The medium (if you need to add the added medium) needs to be verified with the following strains:
- a well-growth positive strain with typical reaction characteristics;
- a weakly positive strain (a strain sensitive to a reagent such as a selection agent in the medium);
- a negative strain that does not have this property;
- a strain that is partially or completely inhibited.
The quality control strain number can refer to GB4789.28-2013 Appendix D "Quality Control Standards for Producers and Laboratory Self-made Media and Reagents"
Or SNT--1538.2-2007 medium performance test practical guide
Intermediate – Intermediate: A material produced during a drug substance processing step that must undergo further molecular modification or refinement to become a drug substance. Intermediates may or may not be isolated. Intermediates are the key products of the previous process of making APIs, which are different in structure from APIs.
for example:
Amoxicillin capsules are called preparations, amoxicillin is called API, and 6-APA is called intermediate.
Ceftriaxone sodium powder is called preparation, sterile ceftriaxone sodium is called API, and 7-ACA is called intermediate.
Our company specializes in providing key intermediates for various APIs
Intermediate is a very important type of fine chemical products. Its essence is a type of "semi-finished product", which is an intermediate product in the production of certain products. For example, if a product is to be produced, it can be produced from intermediates, saving costs and reducing It is widely used in the synthesis of medicines, pesticides, coatings, dyes and spices. In the field of medicine, intermediates are an important link in the industrial chain of the pharmaceutical industry. They are used for some chemical raw materials or chemical products in the process of drug synthesis. In a word, they are used to produce APIs.
Key Intermediates , Pharmaceutical intermediates , Anticancer intermediates , Antitumor Intermediates
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