Various injection technical requirements, various injections, in addition to the general requirements of the preparation, must also meet the following quality requirements:
1、 Sterile; the injection should not contain any living microorganisms and must meet the requirements of sterility testing.
2、 no pyrogen: the injection should not contain pyrogens, especially the dosage of more than 5mL once, for intravenous injection or spinal injection, must be qualified for pyrogen examination.
3、 Clarity: The solution type injection must not contain visible foreign matter or suspension, and should comply with the relevant regulations of the Ministry of Health on the inspection of clarity.
4、 Safety: The injection must be non-toxic and irritating to the body.
5、 Isotonicity: For large doses, intravenous injections should have the same or slightly higher osmotic pressure than plasma.
6、 pH: The injection should have a pH equal to or similar to the blood.
7、 Stable: The injection must have the necessary physical stability and chemical stability to ensure that the product is safe and effective during storage.