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
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.
