Nicotine USP

Product

: NICOTINE USP

Page 1 of 1

Batch No

: NCT/04/07/2023

Mfg Date

: JUL - 2023

A.R. No

: FP/NCT/04/2023

Retest Date

: JUN- 2025

Batch Size

: 150.100 Kg

Date of released

: 26/07/2023

SR.NO

TESTS

SPECIFICATION

RESULTS

1

Appearance

Colorless or brownish viscous Liquid, Volatile, hygroscopic.

Complies

2

Identification A & B

A) IR Spectrophotometer

B) By HPLC

Complies

Complies

3

Solubility

Soluble in water, Miscible with anhydrous ethanol

Complies

4

Water content

NMT 0.50 % w/w

0.16% w/w

5

Specific Optical Rotation

-130.0^o to -143.0^o

-142.21⁰

6

Related Substance By HPLC

6.1

Nicotine related Compound E

NMT 0.30 %

Not detected

6.2

Nicotine related Compound C

NMT 0.30 %

0.03%

6.3

Nicotine related Compound F

NMT 0.30 %

0.01%

6.4

Nicotine related Compound A

NMT 0.30 %

0.01%

6.5

Nicotine related Compound D

NMT 0.30 %

0.12%

6.6

Nicotine related Compound G

NMT 0.30 %

0.01%

6.7

Nicotine related Compound B

NMT 0.30 %

0.03%

6.8

Any Other Unspecified Impurity

NMT 0.10 %

0.01%

6.9

Total Impurities

NMT 0.80 %

0.23%

7

Assay By Potentiometer (Anhydrous basis)

99.0 % to 101.0 %

99.89%

REMARK : As opinion of under signed product is Complies / Does not Complies as per

Prescribe USP Specification.