Local Anesthetic Ropivacaine Injection Mesylate Injection Finished Dosage Form
Contact Person : Jimmy Tian
Phone Number : 86-18602905046
WhatsApp : +8618602905046
| Minimum Order Quantity : | 10,000amps | Price : | to be negotiated |
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| Packaging Details : | 10amps/box, 12boxes /carton | Delivery Time : | for Chinese package, propmt after payment done |
| Payment Terms : | T/T, L/C | Supply Ability : | 100,000 vials /month |
| Place of Origin: | China | Brand Name: | LIBANG |
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| Certification: | Chinese GMP |
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Detail Information |
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| Function: | Anestheic | Dossier: | DMF Available |
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| Pack: | 10amps/box, 12box/carton | Storage: | Stored At 2-25 OC |
| Delivery: | 35 Working Days After Packing CFMD | Cert: | GMP, COPP |
| High Light: | DMF Propofol 10ml,Propofol 10ml COPP,Propofol Anesthesia For Dogs USP EP |
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Product Description
Propofol Injectable Emulsion USP EP CP Anesthetic
Propofol Injectable Emulsionis a well-known anesthetic Finished dosage form, Xi'an Libang Pharmaceutical Co..Ltd developed and lauched firstly Prpofol API in China since 1996.
Propofol, marketed as Diprivan, among other names, is a short-acting medication that results in a decreased level of consciousness and a lack of memory for events. Its uses include the starting and maintenance of general anesthesia, sedation for mechanically ventilated adults, and procedural sedation. It is also used for status epilepticus if other medications have not worked. It is given by injection into a vein, and the maximum effect takes about two minutes to occur and typically lasts five to ten minutes. Propofol is also used for medical assistance in dying in Canada.
The medication appears to be safe for use during pregnancy but has not been well studied for use in this case. It is not recommended for use during a cesarean section. It is not a pain medication, so opioids such as morphine may also be used; however, whether or not they are always needed is not clear. Propofol is believed to work at least partly via a receptor for GABA.
| Test Item | Specification | Result | |
| Appearance | White, aqueous and isotonic emulsion. | Conforms | |
| Identification (1) UV | Maximum absorption at 272 nm. | Corresponds | |
| Identification (2) HPLC | The retention time of the major peak corresponds to that of the standard solution. | Corresponds | |
| pH Value | 6.0～8.5 | 8.2 | |
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Globule size distribution |
MDD should be less than 0.5μm. | Conforms | |
| PFAT5 should not exceed 0.05%. | Conforms | ||
| Free Fatty Acids | The consumed sodium hydroxide TS (0.01mol/L) should be not more than that consumed in the reference solution. | Conforms | |
| Peroxide value | The consumed Na2S2O3 VS (0.01mol/L) should be NMT 1.0 ml. | Conforms | |
| Related compounds | Impurity I | NMT 0.1% | Not detected |
| Impurity II | NMT 0.5% | Not detected | |
| Other impurities (Individual) | NMT 0.2% | Not detected | |
| Other impurities (Total) | NMT 0.4% | Not detected | |
| Anisidine | NMT 5.0 | 1.3 | |
| LPC | NMT 2.0mg/mL | 0.40mg/mL | |
| LPE | NMT0.6mg/mL | Conforms | |
| Glycerol | 20.2～24.8mg | 23.2mg/mL | |
| Phosphorus | 0.40～0.50mg/mL | 0.47mg/mL | |
| Osmolality | 280～330mOsmol/kg | 311mOsmol/kg | |
| Bacterial endotoxins | Less than 0.33EU/mg | Conforms | |
| Sterility test | No evidence of microbial growth | Sterile | |
| Others |
It meets the requirements in Injections (Appendix I B)
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Conforms | |
| Assay | 95.0%～105.0% | 100.8% |
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| Xi'an Libang Pharmaceutical Co., Ltd. |
| 17/F, Block E, Wangzuo International Plaza, No.1, Tangyan Road, Xi’an Hi-tech Zone, Shaanxi, P.R.China 710075 |
| 86-29-89527363 |
| jiangping@libang.com.cn |