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Xi'an Libang Pharmaceutical Co., Ltd.
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Propofol
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Finished Dosage Forms Propofol Injectable Emulsion Propofol 50ml

Finished Dosage Forms Propofol Injectable Emulsion Propofol 50ml

Brand Name: LIBANG
MOQ: 10,000 Vials
Price: to be negotiated
Payment Terms: T/T, L/C
Supply Ability: 100,000 Vials /month
Detail Information
Place of Origin:
China
Certification:
Chinese GMP
Capicity:
500,000,000 Amps/vials
Certificate:
GMP, COPP
Storage:
Stored At 2-25 OC
Delivery:
30 Working Days After Packing CFMD
Stock:
200,000amps In Chinese Pack
Packaging Details:
5vials /box, 20boxes /carton
Supply Ability:
100,000 Vials /month
Highlight:

Finished Dosage Forms Propofol

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Propofol Injectable Emulsion

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Emulsion Propofol 50ml

Product Description

1% Propofol INJECTABLE EMULSION  

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 may also be used; however, wh 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

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 0.400.50mg/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)

 

Conforms
Assay 95.0%~105.0% 100.8%
 

Finished Dosage Forms  Propofol Injectable Emulsion Propofol 50ml 0

 

Finished Dosage Forms  Propofol Injectable Emulsion Propofol 50ml 1