methylene_blue

Methylene Blue USP

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Product Description

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. NoCriteriaLimit/Specification
1.Appearance and OdorDark 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 SolubilitySlightly Soluble in Water and in Alcohol
3.IDENTIFICATION TEST
A. Infrared (IR) AbsorptionThe 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 ChlorideMeets the Requirements
Assay By HPLC (On Dried Basis)97.0% – 103.0%
4.IMPURITIES:
A. Residue on IgnitionNMT 0.15%
B. ArsenicPP
C. Copper or ZincNMT 100 ppm of Zinc and NMT 200 ppm of Copper
5.Organic Impurities
NameRelative RTAcceptance Criteria NMT %
Azure B0.82.5
Unspecified impurity-010.480.10
Unspecified impurity-020.60.10
Total Impurities (Excluding Azure- B)—-0.5
6.Loss on Drying (LOD)8.0% to 22.0%
7.Bacterial EndotoxiRS TestNMT 2.5 USP Endotoxin Units/mL
8.Microbial Enumeration Test: Total aerobic microbial count (TAMC)NMT 102 cfu/g

 

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