Metamizole or dipyrone, is a painkiller, spasm reliever and fever reliever. Like ibuprofen, it has anti-inflammatory effects. It is most commonly given by mouth or by injection. Although it is available over-the-counter in some countries, it is prescription or banned in other countries, due to its potential for adverse events, including agranulocytosis. It is in the ampyrone sulfonate family of medicines.
Dipyrone is a water soluble pyrazolone derivative available in oral, rectal and injectable forms. It has analgesic, antipyretic, antispasmodic, and anti-inflammatory properties. Dipyrone is used most commonly to treat severe pain, particularly, for pain associated with smooth muscle spasm or colic affecting the gastrointestinal, biliary or urinary tracts. It is useful for fever that is refractory to other treatment. Because of the risk of serious adverse effects, such as agranulocytosis, its use is justified only in serious situations where no alternative is available or suitable.
Product Name Metamizole Sodium Monohydrate(Metamizole Sodium,Analgin)
Batch Number 2117090265 Quantity 1000Kg
Mfg Site 10-1 Packing Specification 25Kg/drum
Mfg Date 2017.09.29 Expiry Date 2020.09.28
Certificate No. 2117090265R1 Report Date 2017.10.05
Storage condition Protected from light, preserve in tight containers ,
Contents
Specification:EP8.1
:EP8.1
Results of analysis
RD-5-087 1 1 /:
C/1
Add: Xiangtan Village,Liushi Street,Dongyang City,Zhejiang Province 322104,China.
:,:322104,:0579-86773108
A
ppearance
White or almost white crystalline powder
A
lmost white
crystalline powder
Identification
(1)Comparing with the spectrum obtained with CRS
Conform
(2)Positive Conform
(3)Positive Conf
orm
(4)Reaction of sodium Conform
Appearance of solution
M
eets the requirements
Conform
Acidity or alkalinity
M
eets the requirements
Conform
Related substances
(1) Impurity C: not more than 0.5
C : 0.5%
N
ot detected
(2) I mpurit y E : not more than 15%
E : 0 15
0.04%
(3) Unspecified impurities: for each impurity, not more than 0.05%
: 0.05% 0.04%
(4) Total impurities: not more than 0.5
: 0.5%
Disregard limit: 0.03% : 0.03%
0.
09
Sulfate
s
≤
0.1% <
0.1%
Heavy metals
≤
0.002% <
0.0 02
Loss on drying
4.9~5.3%
5.2%
Assay(dried substance)
()
99.0%~101.0%
99.1%
Solubility
Very soluble in water, sparingly soluble in ethanol (96 percent), practically insoluble in methylene chloride
Conform |
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China Sinopharm International (Shanghai) Co., Ltd. is a comprehensive commercial service enterprise centering international pharmaceutical business.
It is a wholly-owned subsidiary under China Sinopharm International Corporation and is affiliated to China National Pharmaceutical Group Corporation (referred to as "Sinopharm Group"), a Fortune Global 500. Founded in 1985, the company has an net asset of nearly 200 million yuan. It has complete commercial facilities and 23,000 square meters of properties including an office building and shopping malls in Shanghai's West Nanjing Road commercial area and multiple warehouses. International business are carried out based on the platforms of Sinopharm Group and Sinopharm International Pharmaceutical and aims to spread China's high-quality pharmaceutical products and services to the world.
Through close cooperation with major domestic pharmaceutical companies, high-quality pharmaceutical products and overall solutions are provided to overseas customers. We are a well-known pharmaceutical enterprise in China with partners extending to more than 80 countries and regions around the world.