Products – Anmol Chemicals Private Limited

Methylene Blue USP


Identity
Chemical Name: Methylene Blue
Mol. Formula: C16H18ClN3S-3H2O
Mol. Weight: 373.90 g/mol
CAS No.: 61-73-4

 

General Specifications

Test Specification
Characters It occurs as dark greenish crystalline powder with a metallic luster or a dull, dark green or brown powder almost odorless hygroscopic
Identification

Test (A)

Test (B)

Test (C)

Test (D)

 

(a)Infrared absorption

(b) Specified test

(c) Specified Test. Meets the requirement

(d) Specified test

Solubility Soluble in 40 parts of water, 110 parts of alcohol (95%) & in 450 parts of Chloroform
Loss on drying Between 8% and 22%
Residue on ignition Not more than 0.15%
Arsenic Not more than 8 ppm
Copper or zinc Not more than 100 ppm of zinc and not more than 200 ppm of copper.
Chromatographic purity Not more than 1%
Organic volatile impurities Meets the requirements
Bacterial Endotoxins Test Not more than 2.5 USP Endotoxin units/ml
Microbial Enumeration Not more than 102 cfu/g
Assay Not less than 97% and not more than 103% of methylene blue calculated on dry basis

Shelf life, Storage and Packing

It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.

 

Other
We Manufacture Bulk Dugs/API, Excipients, pharmaceuticals (IP/BP/USP/NF/PH. EUR./JP), Speciality Chemicals (Pure/AR/ACS), mineral fortifiers (FCC). our manufacturing facility is GLP, GMP (FDA) approved, ISO 9001, ISO 14001, ISO 22000, FSSC 22000, FSSAI, kosher, halal, COPP and WHO-GMP certified.

Good Manufacturing Practice Certified by World Health Organization (WHO-GMP)
Written Confirmation Certification (WC)
Good Manufacturing Practice (EXCiPACT cGMP)
Good Manufacturing Practice (cGMP)
Good Laboratory Practice (GLP)