Audited Supplier
2g/5ml
Injection
Injection
Adult
Liquid
Injection
Biological Products
Chemical Synthesis
(R)-3-Carboxyl-2 Hydroxy-N, N, N-Trimethyl-1-Propy
C7h15no3
161.20
Colorless Clarity Liquid
It Is Suitable for Chronic Renal Failure Patients
Without
Carton
2g/5ml
China
3004909099
Product Description
The indication of levocarnitine injection is a series of concurrent symptoms caused by secondary carnitine deficiency in patients with chronic renal failure undergoing long-term hemodialysis.
Its clinical manifestations include cardiomyopathy, skeletal myopathy, arrhythmia, hyperlipidemia, hypotension and muscle spasm during dialysis, etc.
Certificate of Analysis
| Product Name | Levocatnitine Injection | ||||
| Batch No. | Sample | Specification | 5ml:2g | ||
| Number | Without | Quantity | 300vials | ||
| Test items | Quality Standard | Test Result | |||
| Characteristics | Colorless clarity liquid | Complies | |||
| Identification | |||||
| Identification by HPLC | In the chromatogram recorded under the content determination item, the retention time of the main peak of the test article shall be the same as that of the main peak of the control article | Complies | |||
| Inspect | |||||
| pH | pH should be 5.5~6.5 | 6.0 | |||
| Content Uniformity | Should be meet requirement | Complies | |||
| Visible Particles | Should be meet requirement | Complies | |||
| Insoluble particles | Should be meet requirement | Complies | |||
| Sterile | Should be meet requirement | Complies | |||
| Assay | It should be contains levocatnitine 90.0%~110.0% of labeled amount. | 101.40% | |||
| Conclusions:The product complies with the requirement of CP standard. | |||||
