Fluorescein Sodium USP
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PRODUCT SPECIFICATIONS
| Name Of Product: | Fluorescein Sodium USP |
| Pharmacopoeial Name: | Fluorescein Sodium USP |
| CAS No: | 518-47-8 |
SPECIFICATIONS
| Sr. No | Criteria | Limit/Specification |
| 1. | APPEARANCE | Orange Red, Fine powder, Hygroscopic |
| 2. | IDENTIFICATION | Must Comply Identification Test A to c |
| 3. | ACRIFLAVINE | No precipitate found |
| 4. | ZINC | No turbidity found |
| 5. | ORGANIC IMPURITIES (HPLC) | 1. RESORCINOL (Impurity A) – NMT 0.5 % 2. PHTHALIC ACID (Impurity B) – NMT 0.5% 3. FLUORESCEIN RELATED COMPOUND C (Impurity C) – NMT 0.5% 4. UNSPECIFIED IMPURITIES (Other Impurity) – NMT 0.1% Unspecified impurity (RT 11.7 Mint.) Unspecified impurity (RT 14.5 Mint.) 5. TOTAL UNSPECIFIED IMPURITIES (Sum of impurities) – NMT 0.5% |
| 6. | WATER DETERMINATION | NMT 17.0% |
| 7. | ASSAY ( On Anhydrous Substance) | 90.0% to 102.0% |
| 8. | Additional test: Pyrogen Free test | Must Pass Test |
RESIDUAL SOLVENTS
| 9. | Acetone | ≤5000 PPM |
MICROBIOLOGICAL QUALITY
| Sr. No | Criteria | Limit/Specification |
| 1. | TAMC | ≤100 CFU/g |
| 2. | TYMC | ≤ 50 CFU/g |
| 3. | Bile tolerant Gram-Bacteria | Absent/g |
| 4. | Staphylococcus Aureus | Absent/g |
| 5. | Pseudomonas Aeruginosa | Absent/g |
| 6. | Escherichia Coli | Absent/g |
| 7. | Salmonella | Absent/g |
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