GMP & ISO Certified Manufacturer of high quality Fluorescein Sodium BP/ Ph Eur.
Macsen Laboratories, world’s leading manufacturer and supplier of Fluorescein Sodium BP/ Ph Eur.
Macsen Laboratories, world’s leading manufacturer and supplier of Fluorescein Sodium BP/ Ph Eur.
| PRODUCT SPECIFICATIONS | |
|---|---|
| Name of Product | Fluorescein Sodium BP/ Ph Eur |
| Pharmacopoeial Name | Fluorescein Sodium BP/ Ph Eur |
| Synonyms | Fluorescein, disodium; Fluorescein disodium salt; C.I. Acid Yellow 73; Fluorescein, Water soluable; Spiro[isobenzofuran-1 (3H), 9'[9H]xanthen] 3-one, 3',6'-dihydroxy-, disodium salt; Uranine |
| CAS No | 518-47-8 |
| Pubchem CID | 10608 |
| Pubchem SID | 462730481 |
| GMP | ✓ |
| WHO-GMP | ✓ |
| WC | Available soon |
| DMF | ✓ |
| US-DMF | ✓ |
SPECIFICATIONS
| SR. No | Criteria | Limit/Specification |
|---|---|---|
| 1 | APPEARANCE | Orange Red, Fine powder, Hygroscopic |
| 2 | SOLUBILITY | Freely soluble in water, soluble in ethanol (96%), practically insoluble in hexane and in methylene chloride. |
| 3 | IDENTIFICATION | Must Comply Identification Test A to D |
| 4 | APPEARANCE OF SOLUTION S | Solution S is clear and orange yellow with yellowish green fluorescence. |
| 5 | pH | In between 7.0 to 9.0 |
| 6 | RELATED SUBSTANCES(HPLC) | 1. Impurity A – NMT 0.5 % 2. Impurity B – NMT 0.5% 3. Impurity C – NMT 0.5% 4. Other Impurity – NMT 0.1% Unspecified impurity (RT 11.7 Mint.) Unspecified impurity (RT 14.5 Mint.) 5. Sum of impurities other than A,B,C – NMT 0.5% |
| 7 | CHLORIDES | Max. 0.25% |
| 8 | SULPHATES | Max. 1.0% |
| 9 | ZINC | Must pass Test |
| 10 | LOSS ON DRYING (Drying at 105°C) | Max. 10.0% |
| 11 | ASSAY (Dried Substance) | 95.0% to 103.0% |
| 12 | 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 |
Buy the best quality Fluorescein Sodium BP/ Ph Eur Used in the field of ophthalmology and used to confirm the presence of residual defect in heart surgery from Macsen Laboratories.
Updates from Macsen Labs on API- Macsen Drugs granted a patent from Indian Patent office for Novel Fluorescein Sodium Synthesis Process
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