98.0% up by HPLC Dexamethasone Sodium Phosphate 55203-24-2
Basic Information
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Product Name
98.0% up by HPLC Dexamethasone Sodium Phosphate 55203-24-2
Substance
Manufacturer(s)
Specifications
- Purity: Assay 97–102% (USP/EP grade)
- IUPAC Name: disodium;[2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate
- EC Number: 219-243-0
- Molecular Weight: 516.4
- Chemical Formula: C22H28FNa2O8P
- CAS Number: 55203-24-2
- Certification Standard: ChP, EP, USP grade
- Regulatory Status: CEP compliant
- Endotoxin Level: <1.2 EU/mg
- Formulation Type: White to yellowish crystalline powder (bulk API)
- Quality Standard: 98% up by HPLC, CEP, EP, USP
- Appearance: White to slightly yellow crystalline powder, free from visible evidence of contamination, very hygroscopic.
- Test Items: Specifications
- Identification: A. The RF value of the principal spot obtained from the test solution corresponds to that obtained from the standard solution.
- Water: ≤16.0%
- Residual Solvents: Acetone ≤ 5000ppm
- Total impurities ≤ 2.0%: 0.40%
- Specific rotation: +74°~ +82°
- pH: 7.7 ~10.5
- Microbial limit: Aerobic Bacteria ≤ 1000cfu/g
- Bacterial endotoxin: <1.2EU/mg
Documents
ISO9001
GMP regulated workshops
GMP
CEP certificates with DMF documents are available
FDA
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