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Rifamycin S
2022-01-20

样品名称

Product Name

利福霉素S

Rifamycin S

批号

Batch No

201405016

代表量

LotQuantity

510Kg

生产日期

MFG. Date

May 16th,2014

包装规格

Pachingy

30Kgper drum

(30Kg/桶)

失效期

EXP.Date

May 15th,2016

引用标准

Standard

In-house

 

检验项目Items of Analysis       标准规定(Standard)      检验结果(Results of analysis)

 

1、Solubility      soluble in chloroform and 2% soluble in methanol      conformed

 

2、Characters:      Yellow or yellowish orange crystalline powder      conformed

 

3、Identification:IR(USP25)       shall have Maxima at 525nm      conformed

 

4、Loss on drying      ≤3.0%      ;2.5%

 

5、Residue on ignition      ≤0.1%      conformed

 

6、Sulphate      ≤0.10%      conformed

 

7、Related Substances

Refampin-O≤1.0%(HPLC)      ≤1.0%      0.03%

25-Desacetyl Rifamycin S       ≤1.0%      ; 0.3%

One peak      0.9%

Total impurities      <3.0%      1.8%

 

8、Assay(as dry)      ≥95.0%       98.2%

 

 

结论(Result)

符合规定(They’dproduct conforms to In-house standard)

备注(Remark)

 


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