Pharmaceutical Grade 122111-03-9 Gemcitabine HydrochloridePharmaceutical Grade 122111-03-9 Gemcitabine HydrochloridePharmaceutical Grade 122111-03-9 Gemcitabine HydrochloridePharmaceutical Grade 122111-03-9 Gemcitabine Hydrochloride

Pharmaceutical Grade 122111-03-9 Gemcitabine Hydrochloride

  • Molecular formula: C9H12ClF2N3O4
  • Molecular Weight: 299.66
  • CAS No.: 122111-03-9
  • Other Name: 4-Amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1H-pyrimidin-2-one hydrochloride
  • Competitive price with high quality

Gemcitabine Hydrochloride


Molecular formula: C9H12ClF2N3O4
Molecular Weight: 299.66
CAS No.: 122111-03-9
Other Name: 4-Amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1H-pyrimidin-2-one hydrochloride
Competitive price with high quality

CERTIFICATE OF ANALYSIS

 

Product Name

Gemcitabine Hydrochloride

Batch No.

2017060302

Date of Test

Jun. 03,2017

Quantity

10.6KGs

Date of Mfg.

Jun. 03,2017

Standard

EP8.3

Date of Report

Jun. 02,2018

 

ITEMS

SPECIFICATIONS

RESULTS

Appearance

White to off-white powder

Conforms

Solubility

Soluble in water, slightly soluble in methanol, practically insoluble in acetone

Conforms

Specific optical Rotation

+43º~+50º

+48.0º

Identification

A

Infrared absorption spectrophotometry (2.2.24) comparision Gemcitabine Hydrochloride CRS

Conforms

B

It gives reaction (a) of chloride (2.3.1)

Conforms

Appearance of solution

Solution Sample in clear(2.2.1) and not more intensely

Conforms

pH

2.0~3.0

2.2

Related substances

Impurity A: ≤0.15%

Impurity C: ≤ 0.2%

Unspecified impurities:  ≤ 0.1%

Total impurities: ≤ 0.4%

0.001%

Not detected

0.03%

0.03%

Heavy metals

≤ 10ppm

Conforms

Sulphated ash

≤ 0.1%

0.03%

Residual solvents

Methanol: ≤ 0.3%

Acetone: ≤ 0.5%

Not detected

0.1%

Assay

97.5%~101.5%

99.1%

Bacteria

< 50cfu/g

< 10cfu/g

Yeast and Mold

< 20cfu/g

< 10cfu/g

E. coli

No detected.

No detected

Conclusion

The above product complies with the standard of EP8.3.


  




 We have developed for nearly 15 years in China. We can provided EP/USP Gemcitabine Hydrochloride with high purity.

Wuhan Ocean Biotech Co., Ltd.

Tel:+86-27-8373-3110

Contact Person:Jane

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