Fluorescein Sodium BP/ Ph Eur

FLUORESCEIN SODIUM BP / Ph Eur

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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 Available soon
WC Available soon
DMF
US-DMF Available soon

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
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