E.C.G-505®
What is E.C.G-505®
E.C.G-505® (Carmellose Calcium) is a chemically modified cellulosic disintegrant containing a Ca chelate structure that confers water insolubility and hydration capacity.
It rapidly absorbs the water required for swelling, resulting in a good short disintegration time.
No organic solvents are used in the manufacturing process, so there is no need to worry about residual solvents.
Basic Information
Product name: E.C.G-505®
Generic name: Carmellose Calcium
Packing style: 20kg slotted cardboard box (2-layer polyethylene inner bag)
Quality-assurance standards: Japanese Pharmacopoeia
Four (4) Pharmacopoeias（JP・USP-NF・EP・ChP）are available.
DMF Registration Number: US Registration No.030379
China Registration No.F20180001742
Acceptance Criteria
| Parameters JP | Specifications JP | Ref. USP-NF | Ref. EP | Ref. ChP | Our test Method |
|---|---|---|---|---|---|
| Description | |||||
| Appearance | a white to yellowish white powder | Meets specification | Meets specification | Meets specification | JP test method |
| pH (1% suspension) | between 4.5 and 6.0 | 4.5 - 6.0 | ― | ― | Ditto |
| Identification | |||||
| Identification (1) | a red-purple color develops | Meets specification | Meets specification | Meets specification | Ditto |
| Identification (2) | a white, flocculent precipitate is produced | Meets specification | Meets specification | Meets specification | Ditto |
| Identification (3) | a brown, flocculent precipitate is produced | Meets specification | Meets specification | Meets specification | Ditto |
| Identification (4) | the solution responds to the tests for calcium | Meets specification | Meets specification | Meets specification | Ditto |
| Purity | |||||
| (1) Alkalinity | no red color develops | Meets specification | Meets specification | Meets specification | Ditto |
| (2) Chloride | not more than 0.36 % | ≦0.36 % | ≦0.36 % | ≦0.3 % | Ditto |
| (3) Sulfate | not more than 1.0 % | ≦1.0 % | ≦1.0% | ≦1.0 % | Ditto |
| Loss on drying | not more than 10.0 % | ≦10.0 % | ≦10.0 % | ≦10.0 % | Ditto |
| Residue on ignition | 10.0 - 20.0 % | 10.0 - 20.0 % | 10.0 - 20.0 % | 10.0 - 20.0 % | Ditto |
| Heavy metals＊ | ― | ― | not more than 0.002% | Ditto | |
＊There is no specification for "Heavy metals in JP/ Carmellose Calcium", but "Heavy metals in JP18/ Carmellose Calcium"
is conducted for the purpose of guaranteeing "Heavy metals in ChP2020/ Carboxymethlcellulose Calcium".
Sulfuric acid is used in the manufacturing process.
Labeling : Regarding particle size , the weight ratio passing through 75µm is more than 95%.
Rational and Molecular formula
Rational formula
：［C6H7O2(OH)3-X-Y(OCH2COO1/2Ca)X(OCH2COOH)Y］n
Average Particle Size・Powder Properties
| Product Name | Average Particle Size※1 | Powder Properties※2 | ||||
| D10 （μm） | D50 （μm） | D90 （μm） | Loose Bulk Density （g/L） | Tap Density （g/L） | Angle of Repose （degree） | |
| E.C.G-505® | 20 | 52 | 114 | 474 | 651 | 44 |
※1 Reference value (laser diffraction type)
※2 Reference value
SEM Image
