| Calcium chloride dihydrate USP/Ph.Eur PARENTEX 1KG | |||
| P0430SR100 | 45974B515DY | ||
| USP/Ph.Eur PARENTEX | 45974B5 | ||
| 10035-04-8 | 112402 | ||
| CaCl2.2H2O | April 2025 | ||
| 147.02 | March 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White, odorless crystalline powder.Is deliquescent and hygroscopic. | white, hard, odorless fragments or granules or crystalline powder. Is deliquescent and hygroscopic. | USP/ Ph.Eur |
| 2 | Solubility | Complies | Freely soluble in water, in alcohol and in boiling alcohol; Very soluble in boiling water. Soluble in ethanol (96%). | USP/ Ph.Eur |
| 3 | Appearance of solution | Complies | Solution should be clear and not more intensely colored than reference solution Y6. | Ph.Eur |
| 4 | Identification (Calcium 1) | Complies | Precipitate should insoluble in 6N acetic acid while soluble in hydrochloric acid. | USP |
| 5 | Identification (Calcium 2) | Complies | The chloroform layer should coloured red. | Ph.Eur |
| 6 | Identification (Calcium 3) | Complies | A white crystalline precipitate should form. | Ph.Eur |
| 7 | Identification (Chloride) | Complies | A curdy white precipitate should insoluble in nitric acid but soluble in 6N ammonium hydroxide. | USP/ Ph.Eur |
| 8 | pH (5% aq soln) | 5.80 | 4.5 - 9.2 | USP |
| 9 | Assay | 99.6% | 99.0% - 107.0% of CaCl2.2H2O | USP |
| 10 | Acidity or Alkalinity | 0.12 mL of 0.01 M sodium hydroxide required | Not more than 0.2 mL of 0.01 M sodium hydroxide or 0.01M Hydrochloric acid should require . | Ph.Eur |
| 11 | Iron, Aluminum & Phosphate | Complies | No turbidity or precipitate should produce. | USP |
| 12 | Magnesium & alkali metals | 0.2% | NMT 0.5% | Ph.Eur |
| 13 | Sulfates | Less than 300 ppm | NMT 300ppm | Ph.Eur |
| 14 | Barium(Ba) | Complies | Any opalescence in the solution is not more intense than reference solution. | Ph.Eur |
| 15 | Iron (Fe) | Less than 10 ppm | NMT 10ppm | Ph.Eur |
| 16 | Total aerobic bacterial count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 17 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm | In-house |
| 18 | Bacterial endotoxins | Less than 2.5 EU/gm | NMT 2.5 EU/gm | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur SPECIFICATION.
Actylis provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
| Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |
Computer Generated Report - Does not require Signature.
