Cellulose Acetate Phthalate USP
| Test | Specification………USP |
| Characters | It occurs as a White, free-flowing powder or colourless flakes; odourless or with a faint odour of
acetic acid; hygroscopic. |
| Identification
Test(A) Test(B) |
(a)Infrared Absorption (b) The solution shows a vivid green fluorescence. |
| Solubility | Freely soluble in acetone; soluble in diethylene glycol and in dioxan; practically insoluble in water, in ethanol (95%), in toluene and in chlorinated and
non-chlorinated aliphatic hydrocarbons. It dissolves in dilute solutions of alkalis. |
| Limit of free acid | Not more than 3.0%. |
| Heavy metals | Not more than 20 ppm |
| Viscosity | 50 to 90 mm2/s |
| Appearance of a film | A thin, colourless, transparent and glossy
film is produced. |
| Sulphated ash | Not more than 0.1%. |
| Water | Not more than 5.0%. |
| Residual solvents | Meets the requirement |
| Assay
Assay of acetyl groups (anhydrous acid-free) Assay of Hydrogen phthaloyl groups (anhydrous, acid-free) |
Not less than and 17.0% and Not more than 26.0%
Not less than and 30.0% and Not more than 40.0% |
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.
