Product Name

Fexofenadine hydrochloride

Batch No.

230108001

MFG. Date

January 2023

Exp. Date

January 2026

ITEMS

SPECIFICATIONS

RESULTS

Description

White to off white crystalline powder; odourless

Complies

Residue on Ignition

193.5℃～196.5℃

194.0℃～195.5℃

Absorption coefficient

E1% 1cm should be 325～345

Complies

Identification

1) Should be positive

Complies

2)IR absorption spectrum should be concordant with RS

Complies

3)Reaction chloride

Complies

Clarity and colour of solution

50% methanol solution be clear and colourless

Complies

PH

3.0～5.0

3.5

Sulphate

NMT 0.02%

0.002%

Loss on drying

NMT0.50%

0.30%w/w

Residue on ignition

NMT0.10%

0.07%

Heavy metals

NMT0.002%

Complies

Residual Solvents

a) Dichloromethane

NMT0.06%

BDL

b)Methanal

NMT0.30%

0.075%

c)Toluene

NMT0.089%

0.042%

Microbiological

Total Plate Count

200 CFU/g

Complies

Yeast & mald

50 CFU/g

Complies

E.Coli

Absent

Complies

Assay (By Titrimetry)

NLT 99.0% ,NMT 101.0%

99.61%

Relted Substances (HPLC)

a)Single impurity

NMT 0.2%

0.16%

b)Total impurity

NMT 0.5%

0.39%

Storage condition

Protected from light , Store in lightly closed containers .This material complies as per in-house specifications.