| Fluorescein Sodium USP | |
| Specification | For : Fluorescein Sodium USP |
| Test | Specification |
| Description | Orange-red, hygroscopic, odorless powder. |
| Solubility | Freely soluble in water; sparingly soluble in alcohol |
| Identification | To comply the tests A ,B & C as per USP |
| Water | not more than 17.0% |
| Zinc | To comply the test as per USP |
| Acriflavine | To comply the test as per USP |
| Assay | NLT 90.0% and NMT 102.0% on AB |
| Fluorescein Sodium E.P. | |
| Specification | For : Fluorescein Sodium EP |
| C. I. Name | Acid Yellow 73 |
| C.A.S. No. | 518-47-8 |
| C. I. No | 45350 |
| Test | Specification |
| Description | A Browinsh Orange powder. Al most odourless and hygroscopic in nature. |
| Absorption Maxima (Buffer = 8) max | Limit : 490-492 nm |
| Absorptivity (A1%,1 CM in Buffer = 8 at max ) | Limit : 2050-2200 |
| Solubility of 2 %Solution IN D.W. | Clear and Orange, Exhibits Yellowish Green Fluorescence |
| Loss on Drying (AT 135 ° C For 1 HR.) |
Limit : Max. 5 % |
| Chloride | Limit : Max. 1% |
| Sulphate | Limit : Max. 1 % |
| Sulphated ASH | Limit : 33.5-35 % |
| Zinc | Limit : Max. 0.1 % |
| Lead | Limit : 10 PPM |
| Arsenic | Limit : 3 PPM |
| Mercury | Limit : 1 PPM |
| Iron Grade | Not More Than 8 Small Iron Particles on Hand Magnet |
| Particle Size | 100 % Pass Through 100 Mesh Size |
| Pioglitazone HCl (In House) | |
| Specification | For : Pioglitazone HCI [In House] |
| Chemical Name | 5-[4-[2-(5-ethyl-2 pyridyl) ethoxy] benzyl] -2,4 thiazolidinedione hydrochloride |
| Test | Specification |
| Description | White to off white powder |
| Identification | A) IR Test should concordant with IR of Standard. B) Gives Reaction of Chloride |
| Solubility | Soluble in dimethyl formamide, Slightly soluble in anhydrous Ethanol, very slightly soluble in Acetone and Acetonitrile, practically insoluble in ether and in water |
| Residue on Ignition | Limit: Max. 0.2% |
| Melting Point | Limit: 193-196°C |
| Heavy Metals | Limit: Max. 20 PPM |
| Loss on Drying (at 105°C, 3hr) | Limit: Max. 0.5%w/w |
| Related Substances (HPLC) | |
| Individual Impurity | Limit: Max. 0.5% |
| Total Impurity | Limit: Max. 1.0% |
| Assay (HPLC)(On Dried Basis) | Limit: 98.0%-101.5% |
