Pharmaceutical Grade Nystatin National Drug Standard Preparation Raw Material Medical Grade Nystatin Complies with Pharmacopoeia Standards for Scientific Research Experiments 1kg

Nystatin Pharmaceutical Grade - Vitamin Class Raw Material

Shaanxi Raw Material Nystatin - Nystatin Raw Material - The Highest Quality Pharmaceutical Grade Nystatin

Pharmaceutical Grade Nystatin - The Highest Quality Raw Material Nystatin (Nystatinum / Mycostatin)

Pharmaceutical Grade Nystatin Alias: Nystatinum / Mycostatin Pharmacopoeia Specifications, Parameters

Pharmaceutical Grade Nystatin (Nystatinum / Mycostatin)

【Chinese Name】Nystatin

【English Name】nystatin dihydrate

【Chinese Alias】Nystatinum; Mycostatin

【CAS Number】1400-61-9

【EINECS Number】215-749-0

【Molecular Formula】C18H28O2

【Molecular Weight】276.4137  

【Packaging Specification】500g/bag, 25kg/drum

【Physicochemical Properties】Yellow or yellowish-brown powder with a special odor and hygroscopicity. Slightly soluble in water, methanol, ethanol. Unstable to air, light, heat, water, acid, or alkali. Antifungal antibiotic.

【Usage】Antifungal spectrum and mechanism similar to amphotericin B, mainly used for skin mucosa, oral, and vaginal Candida albicans infections.

Pharmaceutical Grade Nystatin National Drug Standard Preparation Raw Material Medical Grade Nystatin Complies with Pharmacopoeia Standards for Scientific Research Experiments 1kg

According to the "Chinese Pharmacopoeia 2020 Edition", the quality standards for pharmaceutical grade potassium citrate are as follows:
- Description: White granular crystals or crystalline powder; odorless; slightly hygroscopic. Freely soluble in water or glycerol, almost insoluble in ethanol.
- Identification: Shows identification reactions for potassium salts and citrate.
- Tests:
- Acidity or alkalinity: Dissolve 2.0g in 25ml of water, add 1 drop of thymol blue indicator solution. If blue appears, add 0.20ml of titrant (0.1mol/L), it should turn yellow; add 0.20ml of sodium hydroxide titrant (0.1mol/L), it should turn blue.
- Chloride: Take 0.20g, examine as directed, compare with a control solution prepared from 7.0ml of standard sodium chloride solution, not more intense (0.035%).
- Sulfate: Take 0.20g, examine as directed, compare with a control solution prepared from 3.0ml of standard potassium sulfate solution, not more intense (0.15%).
- Readily carbonizable substances: Take 0.50g, add 5ml of sulfuric acid (containing H?SO? 94.5%~95.5%), heat in a water bath for 1 hour, cool immediately, examine as directed, compare with a control solution (mix 0.5ml of cobalt chloride colorimetric solution with 4.5ml of colorimetric solution), not deeper.
- Oxalate: Dissolve 1.0g in 1ml of water and 3ml of dilute hydrochloric acid, add 4ml of 90% ethanol and 4 drops of calcium chloride test solution, let stand for 1 hour, no turbidity should occur.
- Water: Take about 0.1g, accurately weighed, add 70ml of anhydrous methanol, stir for 5 minutes, determine by water determination method, water content should be 4.0%~7.0%.
- Heavy metals: Dissolve 2.0g in 10ml of water, add 5ml of dilute acetic acid and enough water to make 25ml, examine as directed, heavy metals not more than 10ppm.
- Arsenic: Dissolve 1.0g in 23ml of water, add 5ml of hydrochloric acid, examine as directed, should comply with the regulation (0.0002%).
- Assay: Take about 80mg, accurately weighed, add 20ml of glacial acetic acid and 2ml of acetic anhydride, heat to dissolve, cool, add 1 drop of crystal violet indicator solution, titrate with titrant (0.1mol/L) until the solution turns blue, and correct the titration result with a blank test. Each 1ml of titrant (0.1mol/L) is equivalent to 10.21mg of C?H?K?O?. Calculated on the anhydrous basis, not less than 99.0% of C?H?K?O?.