Fluorescein Sodium Bp / Ph Eur

Fluorescein Sodium USP

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Product Description

PRODUCT SPECIFICATIONS

Name Of Product: Fluorescein Sodium USP
Pharmacopoeial Name: Fluorescein Sodium USP
CAS No:518-47-8

 

SPECIFICATIONS

Sr. NoCriteriaLimit/Specification
1.APPEARANCEOrange Red, Fine powder, Hygroscopic
2.IDENTIFICATIONMust Comply Identification Test A to c
3.ACRIFLAVINENo precipitate found
4.ZINCNo 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 DETERMINATIONNMT 17.0%
7.ASSAY ( On Anhydrous Substance)90.0% to 102.0%
8.Additional test: Pyrogen Free testMust Pass Test

 

RESIDUAL SOLVENTS

9.Acetone≤5000 PPM

 

MICROBIOLOGICAL QUALITY

Sr. NoCriteriaLimit/Specification
1.TAMC≤100 CFU/g
2.TYMC≤ 50 CFU/g
3.Bile tolerant Gram-BacteriaAbsent/g
4.Staphylococcus AureusAbsent/g
5.Pseudomonas AeruginosaAbsent/g
6.Escherichia ColiAbsent/g
7.SalmonellaAbsent/g

 

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