Sodium Starch Glycolate BP
Abstract
Sodium starch glycolate is the sodium salt of carboxymethyl ether. Sodium starch glycolate is a white to off-white, tasteless, odorless, relatively free flowing powder.
Use/Application
Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. It is used as a disintegrant, a suspending agent and as a gelling agent.
Identity
Chemical Name: Sodium Starch Glycolate
General Specifications
| Test | Specification…BP |
| Characters | It occurs as a white or almost white, fine, free flowing powder, very hygroscopic |
| Identification
Test (A) Test (B)
Test (C)
Test(D) |
(a)Test for pH (b)Specified Test. A suspension forms that settles after standing. (c)Specified Test. The solution becomes blue or violet (d) Solution gives the reaction of sodium |
| Solubility | Practically insoluble in methylene chloride. It gives a translucent suspension in water |
| Appearance of solution | The solution is clear and colorless |
| pH | 5.5 to 7.5 |
| Sodium Glycolate | Not more than 2.0% |
| Sodium Chloride | Not more than 7.0% |
| Iron | Not more than 20 ppm |
| Heavy metals | Not more than 20 ppm |
| Loss on drying | Not more than 10.0% |
| Assay | Not more than 2.8% and not less than 4.2% of Na |
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.
