Methylene Blue USP
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PRODUCT SPECIFICATIONS
| Name Of Product: | Methylene Blue |
| Pharmacopoeial Name: | Methylene Blue USP |
| Synonyms: | Methylthioninium Chloride ; Basic Blue 9 ; Zinc free Methylene Blue ; C.I 52015 ; Methylene Blue Trihydrate |
| CAS No: | 7220-79-3 (Trihydrate) / 61-73-4 (anhydrous) |
SPECIFICATIONS
| Sr. No | Criteria | Limit/Specification | |||||||||||||||
| 1. | Appearance and Odor | Dark Green or Blue crystals or crystalline Powder having a bronze-like luster. Is odorless or practically so, and is stable in air. Its Solution in water and in alcohol are deeqblue in Golor | |||||||||||||||
| 2. | Relative Solubility | Slightly Soluble in Water and in Alcohol | |||||||||||||||
| 3. | IDENTIFICATION TEST | ||||||||||||||||
| A. Infrared (IR) Absorption | The IR Spectrum is concordant with the reference spectrum of Methylene Blue. | ||||||||||||||||
| B. Retention Time (RT) | The RT of the major peak of the Sample solution corresponds to that of the Standard Solution. As obtained in the Assay. | ||||||||||||||||
| C. Identification of Chloride | Meets the Requirements | ||||||||||||||||
| Assay By HPLC (On Dried Basis) | 97.0% – 103.0% | ||||||||||||||||
| 4. | IMPURITIES: | ||||||||||||||||
| A. Residue on Ignition | NMT 0.15% | ||||||||||||||||
| B. Arsenic | PP | ||||||||||||||||
| C. Copper or Zinc | NMT 100 ppm of Zinc and NMT 200 ppm of Copper | ||||||||||||||||
| 5. | Organic Impurities | ||||||||||||||||
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| 6. | Loss on Drying (LOD) | 8.0% to 22.0% | |||||||||||||||
| 7. | Bacterial EndotoxiRS Test | NMT 2.5 USP Endotoxin Units/mL | |||||||||||||||
| 8. | Microbial Enumeration Test: Total aerobic microbial count (TAMC) | NMT 102 cfu/g | |||||||||||||||
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