Methylene Blue USP

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. 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
	Name Relative RT Acceptance Criteria NMT % Azure B 0.8 2.5 Unspecified impurity-01 0.48 0.10 Unspecified impurity-02 0.6 0.10 Total Impurities (Excluding Azure- B) —- 0.5
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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