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Gemcitabine HCL 122111-03-9 Gemcitabine HCL 122111-03-9

Gemcitabine HCL 122111-03-9
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Basic information of Gemcitabine HCL

Name

Gemcitabine hydrochloride

Alias

2’,2’-difluorodeoxycytidinemonohydrochloride;
2’-deoxy-2’,2’-difluorocytidinemonohydrochloride;
2’-deoxy-2’,2’-difluoro-cytidinmonohydrochloride;
gemzar;ly188011;ly188011hydrochloride;
2',2'-DIFLUORO-2'-DEOXYCYTIDINE;
2'-DEOXY-2',2'-DIFLUOROCYTIDINE

CAS NO.

122111-03-9

Molecular Formula

C9H12ClF2N3O4

Molecular Weight

299.66

Quality Standard

EP/USP

Package Size

1kg/bag,25kg/drum or per your requests

Use of Gemcitabine HCL

  • Applicable to the treatment of inoperable advanced or metastatic pancreatic cancer and in the treatment of locally advanced or metastatic non small cell lung cancer (NSCLC), in the treatment of advanced non small cell lung cancer, non small cell lung cancer, pancreatic cancer, bladder cancer, breast cancer and other solid tumors.

COA of Gemcitabine HCL

Test

Specification

Result

Characters

White or almost white powder

Conform

Identification

The IR spectrum of sample is concordant with the IR spectrum of Gemcitabine hydrochloride reference standard.

Conform

Chloride

Conform

Solubility

Soluble in water; sparingly soluble in methanol, practically insoluble in alchohol and in polar organic solvents

Conform

pH

2.0 to 3.0

2.2

Specific rotation

+43° to +50°

+49°

Heavy metals

Not more than 10ppm

<10ppm

Residue on ignition

Not more than 0.1%

0.06%

Related substances

Cytosine: not more than0.1%

0.02%

α-anomer: not more than 0.1%

Not detected

Any other impurity: not more than 0.1%

0.04%

Total impurities: not more than 0.2%

0.10%

Bacterial endotoxins

Not more than 0.05 EU/mg

<0.05 EU/mg

bacteria

Not more than 100 CUFU/g

<10 CFU/g

Yeasts & Moulds

Not more than 20 CFU/g

<10 CFU/g

Escherichia coli

Not detected

Not detected

Residual solvents

Methanol: not more than 0.3%

0.0001%

Acetone: not more than 0.5%

0.16%

Isopropyl alcohol: not more than 0.5%

Not detected

Ethylene Dichloride: not more than 5ppm

Not detected

Assay

97.5% to 101.5% ( on as-is basis)

99.4%

Conclusion

Conforms to USP34.



MORE_DETAIL Gemcitabine HCL 122111-03-9

Basic information of Gemcitabine HCL

Name

Gemcitabine hydrochloride

Alias

2’,2’-difluorodeoxycytidinemonohydrochloride;
2’-deoxy-2’,2’-difluorocytidinemonohydrochloride;
2’-deoxy-2’,2’-difluoro-cytidinmonohydrochloride;
gemzar;ly188011;ly188011hydrochloride;
2',2'-DIFLUORO-2'-DEOXYCYTIDINE;
2'-DEOXY-2',2'-DIFLUOROCYTIDINE

CAS NO.

122111-03-9

Molecular Formula

C9H12ClF2N3O4

Molecular Weight

299.66

Quality Standard

EP/USP

Package Size

1kg/bag,25kg/drum or per your requests

Use of Gemcitabine HCL

  • Applicable to the treatment of inoperable advanced or metastatic pancreatic cancer and in the treatment of locally advanced or metastatic non small cell lung cancer (NSCLC), in the treatment of advanced non small cell lung cancer, non small cell lung cancer, pancreatic cancer, bladder cancer, breast cancer and other solid tumors.

COA of Gemcitabine HCL

Test

Specification

Result

Characters

White or almost white powder

Conform

Identification

The IR spectrum of sample is concordant with the IR spectrum of Gemcitabine hydrochloride reference standard.

Conform

Chloride

Conform

Solubility

Soluble in water; sparingly soluble in methanol, practically insoluble in alchohol and in polar organic solvents

Conform

pH

2.0 to 3.0

2.2

Specific rotation

+43° to +50°

+49°

Heavy metals

Not more than 10ppm

<10ppm

Residue on ignition

Not more than 0.1%

0.06%

Related substances

Cytosine: not more than0.1%

0.02%

α-anomer: not more than 0.1%

Not detected

Any other impurity: not more than 0.1%

0.04%

Total impurities: not more than 0.2%

0.10%

Bacterial endotoxins

Not more than 0.05 EU/mg

<0.05 EU/mg

bacteria

Not more than 100 CUFU/g

<10 CFU/g

Yeasts & Moulds

Not more than 20 CFU/g

<10 CFU/g

Escherichia coli

Not detected

Not detected

Residual solvents

Methanol: not more than 0.3%

0.0001%

Acetone: not more than 0.5%

0.16%

Isopropyl alcohol: not more than 0.5%

Not detected

Ethylene Dichloride: not more than 5ppm

Not detected

Assay

97.5% to 101.5% ( on as-is basis)

99.4%

Conclusion

Conforms to USP34.


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