Fluorescein Sodium USP

Category: Active Pharmaceutical Ingredients and Cosmetics

Product Description

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

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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