Shandong medical production license NO.F2014064
Pharmaceutical excipients registration number：F20209990354
Packing specifications: 25 kg/unit（Remark: if the inner packing material is not changed, the packing specification can be added according to the customer's requirement）
Quality standard: ChP2020, USP current edition
Main Usage:
Sodium starch Glycolate is widely used in oral pharmaceutical preparations as disintegrating agent of capsules and tablets. It can be used in tablet directly pressed or wet granulation. It is mainly used as disintegrating agent of solid preparation. Through rapid water absorption, it can achieve rapid and significant swelling, thus disintegrating. At the same time, it has compressibility, which can improve the formability of tablet, increase the hardness of tablet without affecting its disintegration. The general dosage is 2% - 8%.
There are 2 types of Sodium starch Glycolate in our company: Sodium starch Glycolate (type A), corn starch source and Sodium starch Glycolate (type D) potato source. Among them, carboxymethyl starch sodium (type A) has stronger disintegration.
Leading indicator | ChP2020 | USP current edition |
PH | A-Type：5.5-7.5 | A-Type：5.5-7.5 |
D-Type：5.5-7.5 | / | |
Sodium glycollate，% | ≤2.0 | ≤2.0 |
Chloroacetic acid，% | ≤0.2 | / |
sodium chloride，% | A-Type：≤6.0 | ≤7.0 |
D-Type：≤6.0 | ||
Heavy metal，% | ≤0.002 | / |
Loss on drying，% | A-Type：≤10.0 | ≤10.0 |
D-Type：≤10.0 | ||
Content，% | A-Type：2.8-4.2 | A-Type ：2.8-4.2 |
D-Type：2.0-4.0 | / | |
swelling volume | A-Type：≥25ml（Within 15 minutes） | A-Type：≥21ml（Within 20 minutes） |
D-Type：≥15ml（Within 15 minutes） |