PharmEvo (Pvt.) Ltd.

Document # : QCR-2034 Title : Specification and Testing Method for Escitalopram Oxalate

STANDARD TESTING METHOD

Testing Method for Escitalopram Oxalate Raw Material

Name Designation Signature Date

Written/Revised by Kamran Ashfaque Sr. Q.C. Officer
Reviewed by Afzal Ahmed Assistant Q.C. Manager
Approved by Waseem Shehzad A.M Quality Assurance

Date of issue : To be revised : After 3 years

DISTRIBUTION LIST

Distribution Copy no. Copy Holder Date

 Original Q.C. Manager
 1 Q.C. Lab
 2 Q.A. Manager

DOCUMENT CHANGE HISTORY

Review Date Reviewed by Page/Section Nature of amendment Approved by

Updated according to
29.02.2012 A.A All W.S
Manufacturer’s Specification.

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 PharmEvo (Pvt.) Ltd.
Document # : QCR-2034 Title : Specification and Testing Method for Escitalopram Oxalate

Objective:

To Establish a Standard testing procedure for physicochemical testing of Escitalopram Oxalate.

Scope:

This standard testing procedure applies for the physical & chemical tests and estimation of
potency of Escitalopram Oxalate.

Reference:

Manufacturer Specifications

Specifications
S# Tests Specifications
1. Appearance A white to off-white crystalline powder.

2. Solubility Soluble in dimethyl formamide and in dimethyl sulfoxide,

sparingly soluble in methanol and slightly soluble in
dichloromethane.
3. Identification A. By IR
The IR spectrum of test material should correspond to that of Std.
4. Specific optical rotation +10.0º ------ +14.0º

5. Loss on drying Not more than 1.0%

6. Residue on ignition Not more than 0.2%

7. Heavy metals Not more than 0.002%

8. Chromatographic Not more than 0.15% of maximum single impurity.

purity* Not more than 1.0% of total impurities.

9. Content of oxalic acid 20.6% ------ 22.8%

10. Assay : 98.0% ------ 101.0%

Escitalopram Oxalate
(On Dried Basis)

* The Values are accepted from manufacturer’s Certificate of Analysis.

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 PharmEvo (Pvt.) Ltd.
Document # : QCR-2034 Title : Specification and Testing Method for Escitalopram Oxalate

Testing Method
APPEARANCE:

A white to off-white crystalline powder.

SOLUBILITY:

Soluble in dimethyl formamide and in dimethyl sulfoxide, sparingly soluble in methanol and
slightly soluble in dichloromethane.

IDENTIFICATION:

A. By IR: The spectrum of test material and working standard should correspond to each
other.

SPECIFIC OPTICAL ROTATION: (+10.00 ------ +14.00)

Dissolve about 0.5g of test material in 100ml volumetric flask, add 50ml methanol, dissolve
and make up the volume with methanol. Take the specific rotation at a suitable calibrated
polarimeter using methanol as blank.

Sp. Rotation = α = a x v
bxW

Where,
a = Instrument reading
v = Volume of sample’s dilution
b = Path length of cell in decimeter
W = Weight of sample

LOSS ON DRYING: (NMT 1.0%)

Dry about 1g of material in oven at 1050C ±20C for 3 hours.

FORMULA:

% LOD = (W2 – W3) x 100

(W2 – W1)

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 PharmEvo (Pvt.) Ltd.
Document # : QCR-2034 Title : Specification and Testing Method for Escitalopram Oxalate

Where, W1 = Weight of empty crucible

W2 = Weight of crucible + Sample
W3 = Weight of crucible + Residue

RESIDUE ON INGNITION: (NMT 0.2%)

Ignite the crucible at 600 + 500C for 30 min., allow to cool in a desiccator , Weigh about 1gm
of material .Moisten with 1ml of Sulphuric acid , heat gently until white fumes are no longer
evolved. Ignite the residue at 600 + 500C until the residue is completely incinerated. Take out
the crucible and let cool in a desiccator and weigh again. Calculate the weight of residue.

FORMULA:

% ROI = (W3 – W1) x 100

(W2 – W1)
Where,
W1 = Weight of empty crucible
W2 = Weight of crucible + Sample
W3 = Weight of crucible + Residue

ASSAY BY UV: (98.0% to 101.0% on Dried Basis)

Standard Preparation:

Weigh about 50mg of Escitalopram Oxalate working standard in a 100ml volumetric flask add
about 50ml of 0.1N HCl, dissolve and dilute up to the mark with 0.1N HCl. Further dilute 2ml
of above solution in 100ml volumetric flask and dilute up to the mark with 0.1N HCl.

Test Preparation:

Weigh about 50mg of Escitalopram Oxalate test material in a 100ml volumetric flask add
about 50ml of 0.1N HCl, dissolve and dilute up to the mark with 0.1N HCl. Further dilute 2ml
of above solution in 100ml volumetric flask and dilute up to the mark with 0.1N HCl.

Take the readings of standard and test preparations at 239nm using 0.1N HCl as blank.

CALCULATIONS:

%( On As Is Basis) = AT x Ws x 2 x 100 x 100 x Ps x 100

AS 100 100 Wt 2 100

Where,
At = Absorbance of Test solution
As = Absorbance of Standard solution
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 PharmEvo (Pvt.) Ltd.
Document # : QCR-2034 Title : Specification and Testing Method for Escitalopram Oxalate

Ws = Weight of Standard
Wt = Weight of Test Sample
Ps = Potency of working Standard in %

%( On Dried Basis) = % (As Is Basis) x 100

100 - % LOD

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