Products – Anmol Chemicals Private Limited
Sodium Picosulfate USP
Abstract
Sodium Picosulfate is white crystalline powder. It is used as prodrug.
Use/Application
It is used as a laxative
Identity:
Molecular Formula: C18H13NNa2O8S2. H2O
Molecular Weight: 499.4 g/mol
CAS No.: 10040-45-6
General Specifications
| Test | Specification |
| Description | It occurs as a white or almost white, crystalline powder. |
| Identification
Test A Test B |
a. Infrared Absorption b. The solution gives reaction of sodium. |
| Solubility | Freely soluble in water, slightly soluble in alcohol |
| Color of Solution | The Sample solution is not more intensely colored than the Standard solution. |
| Acidity or alkalinity | Specified test. |
| Related substance-
1. 4,4′-[(Pyridin-2-yl)methylene] bisphenol 2. 4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]phenyl sodium sulfate (sodium picosulfate related compound A) 3. Any other individual impurity 4. Total impurities |
1. Not more than 0.2%
2. Not more than 0.2%
3. Not more than 0.10 % 4. Not more than 0.5% |
| Chlorides | Not more than 0.02% |
| Sulfates | Not more than 0.04% |
| Water determination | Between 3.0% to 5.0% |
| Residual solvents | Meets the requirements |
| Assay | Not less than 98.5% to not more than 100.5 % calculated on anhydrous 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)
