| Dextrose anhydrous Cell culture 250GM | |||
| C7530SG250 | 38784H820IV | ||
| Cell culture | 38784H8 | ||
| 50-99-7 | 88348 | ||
| C6H12O6 | September 2022 | ||
| 180.16 | August 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | White crystalline powder. Is odorless, and has a sweet taste. | Colorless crystals or white, crystalline or granular powder. Is odorless, and has a sweet taste. |
| 2 | Solubility | Complies | Very soluble in boiling water; freely soluble in water; soluble in boiling alcohol; slightly soluble in alcohol. |
| 3 | Assay (anhydrous substance) | 99.95% | 97.5% - 102.0% |
| 4 | Identification (By IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of standard. |
| 5 | Identification (By HPLC) | Complies | The principal peak from the sample solution is similar in retention time and size to the principal peak from standard solution A. |
| 6 | Identification (By Water) | 0.87% | NMT 1.0% |
| 7 | Appearance of solution | Complies | The solution should clear and not more intensely coloured than reference solution BY7 |
| 8 | Color and Clarity of solution | Complies | The Sample solution should clear and not more intensely coloured than reference solution. |
| 9 | Titrable acid | Less than 0.002 meq/g | NMT 0.002 meq/g |
| 10 | Conductivity | 17 µS/cm | NMT 20 µS/cm |
| 11 | Specific rotation[a]D25° | 52.7° | 52.5 – 53.0° |
| 12 | Insoluble matter in water | 0.003% | NMT 0.005% |
| 13 | Chloride (Cl) | Less than 0.01% | NMT 0.01% |
| 14 | sulfate (as SO4) | Less than 0.005% | NMT 0.005% |
| 15 | Heavy metals (as Pb) | Not detected | NMT 5ppm |
| 16 | Iron (Fe) | Not detected | NMT 5ppm |
| 17 | Related substances: sum of impurities A (maltose) and B (isomaltose) | 0.14% | NMT 0.4% |
| 18 | Related substances: Impurity C (maltotriose) | 0.05% | NMT 0.2% |
| 19 | Related substances: Impurity D (fructose) | Not detected | NMT 0.15% |
| 20 | Related substances: unspecified impurity | 0.03% | NMT 0.10% |
| 21 | Related substances: the total amount of all other impurities | 0.22% | NMT 0.5% |
| 22 | Dextrins | Complies | The sample dissolve completely |
| 23 | Soluble starch, sulfite | Less than 15ppm | NMT 15ppm |
| 24 | Water (By KF) | 0.87% | NMT 1.0% |
| 25 | Sulfated ash | 0.01% | NMT 0.02% |
| 26 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 27 | Total Yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 28 | Bile-tolerant gram negative bacteria | Absent/gm | should be absent/gm |
| 29 | Escherichia coli | Absent/gm | should be absent/gm |
| 30 | Pseudomonas aeruginosa | Absent/gm | should be absent/gm |
| 31 | Staphylococcus aureus | Absent/gm | should be absent/gm |
| 32 | Candida albicans | Absent/gm | should be absent/gm |
| 33 | Salmonella | Absent/10gm | should be absent/10gm |
| 34 | Bacterial endotoxins | Less than 10 IU/gm | NMT 10 IU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, BP 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.
