| Sodium metabisulfite USP-NF/Ph.Eur PARENTEX PLUS 500GM | |||
| I1630SG500 | 43070G805CX | ||
| USP-NF/Ph.Eur PARENTEX PLUS | 43070G8 | ||
| 7681-57-4 | 102358 | ||
| Na2S2O5 | March 2024 | ||
| 190.1 | February 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Almost white crystalline powder. | White or almost white to yellowish crystalline powder or colorless crystals. |
| 2 | Solubility | Complies | Freely soluble in water and in glycerin. Slightly soluble in ethanol (96%) and alcohol. |
| 3 | Identification A (By pH) | 4.15 | 3.5 to 5.0 |
| 4 | Identification (Reaction of sulfates) | Complies | White precipitate should form. |
| 5 | Identification (Reaction of sodium) | Complies | A dense white precipitate should form. |
| 6 | Identification (Sulfite) | Complies | A filter paper moistened with mercurous nitrate solution should blacken. |
| 7 | Appearance of solution | Complies | Clear and colorless solution. |
| 8 | pH | 4.15 | 3.5 to 5.0 |
| 9 | Thiosulfates | Complies | The solution should remain clear for at least 15 min. |
| 10 | Limit of Thiosulfate | Less than 0.05% | NMT 0.05% |
| 11 | Iron (Fe) | Less than 20ppm | NMT 20ppm |
| 12 | Limit of Chloride | Less than 0.05% | NMT 0.05% |
| 13 | Assay(as SO2) | 65.1% | 65.0%- 67.4% |
| 14 | Assay | 96.6% | 95.0% - 100.5% |
| 15 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 16 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 17 | E.coli | Absent/gm | should be absent/gm |
| 18 | Salmonella | Absent/10 gm | should be absent/10gm |
| 19 | Pseud. aeruginosa | Absent/gm | should be absent/gm |
| 20 | Staphylococcus aureus | Absent/gm | should be absent/gm |
| 21 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
| 22 | Bacterial endotoxin test | Less than 6.0 EU/gm | NMT 6.0 EU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur SPECIFICATION.
FINAR 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.
