98% up by HPLC EP/USP GEMCITABINE HYDROCHLORIDE 122111-03-9
Basic Information
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Product Name
98% up by HPLC EP/USP GEMCITABINE HYDROCHLORIDE 122111-03-9
Substance
Manufacturer(s)
Specifications
- Purity: Assay 97.5–101.5% (EP/USP grade)
- IUPAC Name: 4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one;hydrochloride
- EC Number: 601-823-3
- Molecular Weight: 299.66
- Chemical Formula: C9H12ClF2N3O4
- CAS Number: 122111-03-9
- Certification Standard: USP, BP, EP, JP grade
- Endotoxin Level: ≤0.05 EU/mg
- Formulation Type: White powder (bulk API)
- Quality Standard: EP / USP, medical grade
- Appearance: White powder
- Test: Specification
- Characters: White or almost white powder
- Identification: The IR spectrum of sample is concordant with the IR spectrum of Gemcitabine hydrochloride reference standard.
- Chloride: Conform
- Solubility: Soluble in water; sparingly soluble in methanol, practically insoluble in alchohol and in polar organic solvents
- pH: 2.0 to 3.0
- Specific rotation: +43° to +50°
- Heavy Metals: Not more than 10ppm
- Residue on ignition: Not more than 0.1%
- Related substances: Cytosine: not more than 0.1%
- Bacterial endotoxins: Not more than 0.05 EU/mg
- Bacteria: Not more than 100 CUFU/g
- Yeasts & Moulds: Not more than 20 CFU/g
- Escherichia coli: Not detected
- Residual Solvents: Methanol: not more than 0.3%
- Assay: 97.5% to 101.5% ( on as-is basis)
Documents
ISO9001
GMP regulated workshops
GMP
CEP certificates with DMF documents are available
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