產(chǎn)品

Sample

克霉唑

Clotrimazole

批號

Batch No.

20190305

數(shù)量

Quantity

500KG

生產(chǎn)日期

Manufacturing Date

2019.3.3

CAS編號

Cas Number

23593-75-1

有效日期

Expiry Date

2021.3.2

檢驗(yàn)項(xiàng)目

Items

標(biāo)準(zhǔn)要求

Standard

結(jié)果

Results

性狀

Characteristic 

白色至淺黃色結(jié)晶性粉末

White to pale yellow,crystalline powder

符合規(guī)定

Conforms

溶解度

Solubility

幾乎不溶于水易溶于甲醇、丙酮、氯仿和酒精

Practically insoluble in water,freely soluble in methanol,in acetone,in chloroform. and in alcohol

符合規(guī)定

Conforms

鑒別

Identifieation

紅外，薄層色譜鑒別

Infrared Absorption

thin-layer chromatography identification

符合規(guī)定

Conforms

相關(guān)物質(zhì)A

Related Compound A

≤0.2%

符合規(guī)定

Conforms

熔點(diǎn)

Melting Point

141-145℃

143-144℃

咪唑

Iminazole

≤0.5%

符合規(guī)定

Conforms

干燥失重

Loss on Drying

≤0.5%

0.11%

灼燒殘渣

Residue on ignition

≤0.1%

0.01%

重金屬

Heavy Metals

≤0.001%

符合規(guī)定

Conforms

菌落總數(shù)

Total Plate Count

＜1000cfu/g

符合規(guī)定

Conforms

總酵母菌和霉菌

Total Yeast and Mould

＜100cfu/g

符合規(guī)定

Conforms

大腸埃希菌

E.Coli

末檢出

Negative

符合規(guī)定

Conforms

含量

Assay

98%-102%

99.1%

判定

Conclusion

產(chǎn)品符合USP36標(biāo)準(zhǔn)

Conform to USP36

質(zhì)量科長：                                            復(fù)核人：                                           檢驗(yàn)人：

Chief of Quality Man GLNG Section      Head of Analytical Department           Inspector