Topnotch Chemicals Private Limited

Sr.No.

TEST

SPECIFICATIONS

1.

Description

Off White to Pale Yellow Crystalline Powder.

2.

Solubility

Soluble in MDC.

3.

Loss on drying at   45-50 ⁰C for 4 hrs

NMT 0.5 % w/w

4.

Identification by TLC

Any spot in the chromatogram other than the principle spot obtained with solution (1) in not more intense than the principle spot obtained with solution (2)

6.

Melting Point

Between 123⁰C and 127⁰C

7.

Purity by HPLC

NLT 98.0 % (On Area %)

9.

Related Substance

( By HPLC )

1. Isomer of Dichloro Fluorene  : NMT 1.0 %

2. Total impurity : NMT 2.0 %

Specification

1

DESCRIPTION

Pale yellow to yellowish to light powder.

2

IDENTIFICATION BY HPLC

The retention time of the major peak in chromatogram of the sample preparation should correspond to that in the chromatogram of the standard preparation, as obtained in the test for chromatographic purity by HPLC.

3

LOSS ON DRYING

Not more than 0.5%

4

SULPHATED ASH

Not More than 1.0%

5

MELTING RANGE

Report Value

6

CHROMATOGRAPHIC Purity by HPLC

Not less than 98%

7

ASSAY BY HPLC

Not less than 98.0% (By HPLC; ODB).

SR.No.

Test

Specifications

1

Loss on Drying

@80⁰C For 2 Hours

> 0.5 %

2

Identification by

TLC

Single Spot

3

Melting Point

110-114 ⁰C

4

Assay

(By H.P.L.C.)

Above 99.0%

SR.No.

Test

Specifications

1

Loss on Drying

@90⁰C For 2 Hours

Not more than 0.5% w/w

2

Identification

HPLC-The retention time of major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay

3

Related Substance

TLC : Any impurity not more than 2.0%

4

Melting Range

197.0-200 ⁰C

5

Assay

(By H.P.L.C.)

Not less than 98.0%