| Calcium acetate CDMF PARENTEX PLUS 1KG | |||
| I3405SR100 | 46698B413GY | ||
| CDMF PARENTEX PLUS | 46698B4 | ||
| 62-54-4 | 114106 | ||
| (CH3COO)2Ca.xH2O | July 2025 | ||
| 158.17 | June 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | White, odorless hygroscopic, crystalline powder. | White, odorless or almost odorless, hygroscopic, crystalline powder. | USP |
| 2 | Solubility | Complies | Freely soluble in water; slightly soluble in methanol; practically insoluble in acetone, in dehydrated alcohol, and in benzene. | USP |
| 3 | Identification ( For calcium) | Complies | A white precipitate which is insoluble in 6 N acetic acid but dissolve in hydrochloric acid should form. | USP |
| 4 | Identification ( For Acetate 1) | Complies | A dark colour develops or a blue precipitate should form. | USP |
| 5 | Identification ( For Acetate 2) | Complies | A red colour that destroyed or a blue precipitate should form. | USP |
| 6 | Assay (Anhydrous basis) | 99.93% | 99.0% - 100.5% | USP |
| 7 | Arsenic (As) | Less than 3 ppm | NMT 3ppm | USP |
| 8 | Chloride (Cl) | Less than 0.05% | NMT 0.05% | USP |
| 9 | Sulphate (SO4) | Less than 0.06% | NMT 0.06% | USP |
| 10 | Fluoride(F) | 27 ppm | NMT 50ppm | USP |
| 11 | Nitrate (NO3) | Complies | The blue color persists for NLT 10 min. | USP |
| 12 | Readily oxidizable substances | Complies | The pink colour in the supernatant is not completely discharged. | USP |
| 13 | pH | 7.64 | 6.3 - 9.6 | USP |
| 14 | Water | 5.89% | NMT 7.0% | USP |
| 15 | Appearance of solution | Complies | The sample solution should be clear and colourless. | USP |
| 16 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU/gm | In-house |
| 17 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm | In-house |
| 18 | E.coli | Absent/gm | Should be absent/gm | In-house |
| 19 | Bacterial endotoxins test | Less than 0.1 Eu/mg | Less than 0.1 Eu/mg | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE 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.
