Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT NF, JP, Ph. Eur., BP suitable for use as excipient, SAFC®

供应商: MERCK PRODUCTION CHEMICALS

Synonyms: D-山梨糖醇

1.11597.2500
MERP1.11597.2500EA 0 CNY
MERP1.11597.2500
Parteck® SI 400 LEX (Sorbitol), EMPROVE® EXPERT NF, JP, Ph. Eur., BP suitable for use as excipient, SAFC®
D-山梨醇

Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (#).


Certifications: corresponds to Ph. Eur., BP, NF, JP

分子式: HOH₂C(CH(OH))₄CH₂OH
分子量: 182.17 g/mol
沸点: 295
溶点: 94…98 °C
密度: 1.524 g/cm³ (20 °C)
闪点: >100 °C
存储条件: Ambient
MDL编号: MFCD00004708
CAS号: 50-70-4
EINECS: 200-061-5
Merck Index: 13,08797
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产品技术规格

Assay (HPLC, calc.on anhydrous substance) 97.0 - 100.5 %
Identity passes test
pH-value (10 %; water) 3.5 - 7.0
Appearance of solution (25 %; water) passes test
Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance) +4.0 - +7.0 °
Conductivity (25°C) (20 %; water) ≤ 20
Chloride (Cl) ≤ 0.002 %
Sulfate (SO₄) ≤ 0.006 %
Heavy metals (as Pb) ≤ 5 ppm
As (Arsenic) ≤ 1.3 ppm
Ni (Nickel) (#) ≤ 1 ppm
Pb (Lead) ≤ 0.5 ppm
Related substances (HPLC, EP) (Major impurity (Mannitol)) ≤ 2.0 %
Related substances (HPLC, EP) (Sum of all impurities) ≤ 3.0 %
Reducing sugars after hydrolysis/total sugar (as glucose) ≤ 0.8
Reducing sugars (as glucose) ≤ 0.11 %
Sulfated ash ≤ 0.02 %
Loss on drying ≤ 2.0 %
Water ≤ 1.5 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Microbiological test passes test
Colony count (aerobic bacteria (TAMC)) ≤ 10²
Colony count (Yeasts and moulds (TYMC)) ≤ 10²
Salmonella spp. in 10g Substance not detectable
E.coli in 1g substance not detectable
Pseudomonas aeruginosa in 1g substance not detectable
Staphylococcus aureus in 1g substance not detectable
Candida albicans In 1g substance not detectable
Endotoxins ≤ 1

规格

Environmentally Preferable

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