| Succinic acid CDMF 500GM | |||
| 93744SG500 | 34262D210CU | ||
| CDMF | 34262D2 | ||
| 110-15-6 | 74269 | ||
| (CH2COOH)2 | March 2021 | ||
| 118.09 | February 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White, odorless crystals | White, odorless crystals (USP-NF/Ch.P) |
| 2 | Solubility | Passes | Soluble in water, in alcohol, and in glycerine; freely soluble in boiling water. (USP-NF) |
| 3 | Identification (By IR) | Complies | The infrared spectrum should be concordant with that of succinic acid standard. It exhibits absorption at the wave numbers of about 1690 cm-1, 1424 cm-1, 1314 cm-1, 1206 cm-1, and 920 cm-1 (USP-NF/Ch.P) |
| 4 | Identification (By Chromatographic identity) | Complies | The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. (USP-NF) |
| 5 | Assay(HPLC) | 99.8% | 99.0% - 100.5% (USP-NF) |
| 6 | Residue on ignition | 0.009% | NMT 0.025% (USP-NF/Ch.P) |
| 7 | Melting range | 187.0°C - 189.0°C | 185.0°C - 190.0°C (USP-NF/Ch.P) |
| 8 | Potassium permanganate- reducing substances | Passes | The color of solution does not disappear within 3 min. (JP) |
| 9 | Total aerobic microbial count | Less than 100 cfu/g | NMT 100 cfu/g (In-house) |
| 10 | Total Yeast and mold count | Less than 10 cfu/g | NMT 10 cfu/g (In-house) |
| 11 | E.coli | Absent/g | Should be absent /g (In-house) |
| 12 | Salmonella | Absent/10 g | Should be absent /10 g (In-house) |
| 13 | Pseudomonas aeruginosa | Absent/g | Should be absent /g (In-house) |
| 14 | Staphylococcus aureus | Absent/g | Should be absent /g (In-house) |
| 15 | Bile-tolerant gram negative bacteria | Absent/g | Should be absent /g (In-house) |
| 16 | Bacterial endotoxin test | Less than 2.5 EU/g | NMT 2.5 EU/g (In-house) |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, JP and Ch.P 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.
