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FLUORESCEIN SODIUM USP

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Fluorescein sodium is the sodium salt of fluorescein and a synthetic organic fluorescent dye. It has been used medically in ophthalmology for retinal angiography for many years.

Macsen Drugs granted a patent from Indian Patent office for Novel Fluorescein Sodium Synthesis Process

The Indian patent office has granted a patent to Macsen Drugs, a unit of the Macsen Labs group. The patent relating to the field of chemistry is titled “Process for the preparation of crystalline fluorescein Sodium from diacetylfluorescein or Fluorescein”. The patent concerns a novel process for synthesizing the compound Fluorescein Sodium. Read More.

GMP & ISO Certified Manufacturer of high quality Fluorescein Sodium USP.
Macsen Laboratories, world’s leading manufacturer and supplier of Fluorescein Sodium USP.
PRODUCT SPECIFICATIONS
Name of Product Fluorescein Sodium USP
Pharmacopoeial Name Fluorescein Sodium USP
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 Our Results
1 APPEARANCE Orange Red, Fine powder, Hygroscopic Orange Red, Fine powder, Hygroscopic.
2 IDENTIFICATION Must Comply Identification Test A to c Complies A to C tests
3 ACRIFLAVINE No precipitate found Passes Test
4 ZINC No turbidity found Passes Test
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%
Passes Test
Not detected
Not detected
0.19 %
0.016%
0.007%
0.023%
6 WATER DETERMINATION NMT 17.0% 8.37%
7 ASSAY ( On Anhydrous Substance) 90.0% to 102.0% 98.79%
8 Additional test: Pyrogen Free test Must Pass Test Passes Test

RESIDUAL SOLVENTS

9 Acetone ≤5000 PPM < 5 PPM

MICROBIOLOGICAL QUALITY

SR. No Criteria Limit/Specification Test Results
1 TAMC ≤100 CFU/g <10 CFU/g
2 TYMC ≤ 50 CFU/g <10 CFU/g
3 Bile tolerant Gram-Bacteria Absent/g Absent
4 Staphylococcus Aureus Absent/g Absent
5 Pseudomonas Aeruginosa Absent/g Absent
6 Escherichia Coli Absent/g Absent
7 Salmonella Absent/g Absent
Buy the best quality Fluorescein Sodium USP Used in the field of ophthalmology and used to confirm the presence of residual defect in heart surgery from Macsen Laboratories.
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