Ankleshwar, Gujarat, India
Our Products
Certificate Of Analysis
| Test | Specification |
|---|---|
| Description | White to almost white crystalline powder. |
| Solubility | Soluble in Dimethyl formamide, very slightly soluble in acetonitrile. Practically insoluble in water and in ether |
| Identification | By IR - The IR absorption spectrum of the substance being examined in KBr disc should be concordant with the IR spectrum obtained from Pioglitazone HCL working standard. Chloride Test- Crudy white precipitates should be produced with the chemical test. |
| Appearance of solution (5.0% w/v in methanol) | Solution is clear and not more intensely colored than reference solution BYS7. |
| Loss on drying at 105oC | Not more than 0.50% w/w. |
| Heavy metals | Not more than 20 ppm. |
| Sulphated ash | Not more than 0.1% |
| Related substances (By HPLC) | Single Impurity - Not more than 0.50% Total impurities - Not more than 1.0 % |
| Assay ( by Titrimetry ) | Not less than 98.0 % and not more than 102.0 % w/w calculated on dried basis. |
Certificate Of Analysis
| Test | Specification |
|---|---|
| Description | White Crystals |
| Solubility | Freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone, and in Methylene chloride. |
| Identification | Infrared absorption - Infra-red absorption spectrum of sample preparation should correspond to that of the standard preparation of Metformin Hydrochloride Chloride Test- Gives the reaction of chlorides |
| Appearance of solution | The solution should be clear and colorless |
| Related substances(by HPLC) | Impurity A - Not more than 0.02% Any other impurity - Not more than 0.1% |
| Heavy metals | Not more than 10 ppm |
| Sulphated ash | Not more than 0.1% |
| Loss on drying | Not more than 0.5% |
| Assay ( by Titrimetry ) | Not less than 98.50% and not more than 101.0 % ( On dried basis) |
Certificate Of Analysis
| Test | Specification |
|---|---|
| Description | A White to off white powder. |
| Solubility | Sparingly soluble in Methanol |
| Identification | By IR - IR spectrum should be correspond to structure and standard |
| Water | Not more than 1.0 % w/w |
| Sulphate ash | Not more than 0.50% w/w. |
| Heavy metals | Not more than 20 ppm |
| Related substances | Highest individual impurity - Not more than 0.5 % w/w Total impurities - Not more than 1.0% w/w |
| Assay (By HPLC, on anhydrous basis) | Between 98.0 % - 102.0 % w/w |
Certificate Of Analysis
| Test | Specification |
|---|---|
| Description | White powder |
| Solubility | Freely soluble in acetone, in Chloroform, in methanol, and in toluene, insoluble in water. |
| Identification | By IR -The I.R Spectrum of the substance being examined in mineral oil is concordant with the IR spectrum obtained from Loratadine working standard By HPLC - The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. |
| Melting Range | Between 132 oC and 137 oC |
| Loss on drying | Not more than 0.5 % (w/w) |
| Residue on Ignition | Not more than 0.1 % (w/w) |
| Heavy Metals | Not more than 10 ppm. |
| Related substances (By HPLC) | Impurity-A* - Not more than 0.2 % Unknown impurity - Not more than 0.1 % Total Impurities - Not more than 0.3 % |
| Assay ( by Titrimetry ) | Not less than 98.5 % and not more than 101.0 % of Loratadine, calculated on dried basis. |
