Methylene Blue USP
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
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.
