(Coloring agent)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility producing Ferric Oxide, known for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.
Our cutting-edge technology ensures the production of high-quality Ferric Oxide, meeting the highest standards for performance and consistency.
Applications: MOLOXIDE™ Fe3 is widely used in the pharmaceutical industry as a coloring agent, opacifying agent and light-protective excipient. It is used to impart red, yellow, brown or black colors to tablets, capsules, powders and other dosage forms. It helps improve the appearance and identification of pharmaceutical products. Iron oxides are commonly incorporated into film and sugar coatings to provide color and improve the visual appearance of tablets.
| # | TEST | SPECIFICATION - USP |
|---|---|---|
| 1 | Description | It occurs as a powder exhibiting two basic colors (red and yellow), or other shades produced on blending the basic colors. |
| 2 | Identification Test (A) |
(A) It gives reaction for ferric salts. |
| 3 | Solubility | It is insoluble in water and in organic solvents. |
| 4 | Mercury | Not more than 3 µg/g. |
| 5 | Limit of Arsenic | Not more than 3 µg/g. |
| 6 | Limit of Lead | Not more than 0.001% |
| 7 | Water soluble substances | Not more than 1.0%. |
| 8 | Acid insoluble substances | Not more than 0.3%. |
| 9 | Organic colours and Lakes | No peak above the noise level with a slope greater than +0.001 absorbance unit/nm is found. |
| 10 | Assay | Not less than 97.0% and not more than 100.5% on the ignited basis. |
MOLOXIDE™ Fe3 is packed in HDPE bag or HDPE drum with double PE liners inside having bar-coded label and tamper-evident seal.
The shelf life is 5 years. Preserve in well-closed containers.
This document and any information provided herein does not constitute a legally binding obligation of Muby Chem and has been prepared in good faith and is believed to be accurate as of the date of issuance. Unless expressly agreed otherwise in writing in a supply contract or other written agreement between you and Muby Chem: