STANDARD OPERATING PROCEDURE

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

DEPARTMENT: QUALITY CONTROL SECTION: QUALITY
CONTROL
Subject: Anxiorid 0.25mg tablet Specification ISO SOP No. QC/TAB- 07
Supersedes date: Jan, 2013
SOP No.: Nil
Issue date To be revised on: Revision no. Page 1 of 7
05-01-2018 05-01-2023 01
Written/Revised by: Checked by: Approved by: Authorized by:

Sign. Sign. Sign. Sign.

Name Abbas Ali Shah Name Taimur Rehman Name Irfan Ali Name M.Abdullah
Desig. QC Analyst Desig. Sr.QC Analyst Desig. Asst: QC Manager Desig. QC Manager

Product Specification (Bulk):

a) Description: Yellow color granular powder.

b) Av. weight of 1.50g.

10 Tablets: (1.42 -1.57g)

c) Loss on drying: NMT 3%(Granule)

d) Assay: 0.25mg / Tablet

Alprazolam: (90– 110%)
 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY ASSURANCE SECTION: QUALITY
CONTROL
Subject: Anxiorid 0.25mg tablet Specification ISO SOP No. QC/TAB- 07
Supersedes date: Jan, 2013
SOP No.: Nil
Issue date To be revised on: Revision no. Page 2 of 7
05-01-2018 05-01-2023 01

Product Specification (Core):

a) Monograph
Reference No: USP 43

b) Description: Yellow color oblong shape tablets having bisection line on one
Side and plane on the other side.

c) Av. weight of 1.50g

10 Tablets: (1.42 – 1.57g)

d) Thickness: 3.8 – 4.4mm

e) Hardness: NLT4 kg/cm2

f) Friability: NMT 1%

g) Dosage Uniformity: Meets USP Requirement

h) Disintegration time: NMT 15 minutes.

i) Assay: 0.25mg / Tablet

Alprazolam: (90.0%---110.0%)

j) Dissolution: NLT 80%

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 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY ASSURANCE SECTION: QUALITY
CONTROL
Subject: Anxiorid 0.25mg tablet Specification ISO SOP No. QC/TAB- 07
Supersedes date: Jan, 2013
SOP No.: Nil
Issue date To be revised on: Revision no. Page 3 of 7
05-01-2018 05-01-2023 01

Test Methods:

Description: Visually examines a representative number of tablets for

Color, shape making and presence of foreign matters

Dosage Meet USP Requirements

Uniformity:
Disintegration Fill in 1000 ml beaker with water and ensure that the highest
Time: point of wire mesh is atleast 25 mm below the surface of the
water and its lowest point is atleast 25 mm above the bottom
of the beaker. Adjust the temperature of water to 37ºC + 2º C.
Place one tablets in each of the six tubes of the basket adds a
disk to each tube and operate the apparatus. Meanwhile start
the stopwatch. Observe the tablets. Stop the stopwatch when
the last gets disintegrated. The tablets pass the test, if the last
tablet gets disintegrated in specified D time indicated in the
specification. If one or two tablets fail to disintegrate, repeat
the test on 12 additional tablets. Not less than 16 tablets of
total 18 tablets tested disintegrate. If tablet adhere to the disc
and the preparation failed to comply, repeat the test omitting
the disc.

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 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY ASSURANCE SECTION: QUALITY
CONTROL
Subject: Anxiorid 0.25mg tablet Specification ISO SOP No. QC/TAB- 07
Supersedes date: Jan, 2013
SOP No.: Nil
Issue date To be revised on: Revision no. Page 4 of 7
05-01-2018 05-01-2023 01

Dissolution: Perform dissolution test on six tablets with the following

Parameter.

Medium: Buffer solution (500ml)

Apparatus: I USP (Basket)

RPM: 100

Time: 30 minutes.

Buffer Stock Solution: Dissolve 80gm of monobasic potassium phosphate and 20gm
of dibasic potassium phosphate in 1000ml of water. And
adjust pH with dilute potassium hydroxide or dilute phosphoric
acid up to 6.0.

Buffer Solution: Dilute 400ml of Buffer stock solution with 3600ml of distilled
water.

Chromatographic Conditions:

Column : 4mm x 10-cm (ODS) (5µ) (L7)

Temperature : Ambient
Flow rate : 1ml / min
Wavelength : 254 nm
Attenuation : 5 (adjustable)
Inject volume : 20µl

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 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY ASSURANCE SECTION: QUALITY
CONTROL
Subject: Anxiorid 0.25mg tablet Specification ISO SOP No. QC/TAB- 07
Supersedes date: Jan, 2013
SOP No.: Nil
Issue date To be revised on: Revision no. Page 5 of 7
05-01-2018 05-01-2023 01

Mobile Phase: Acetonitrile : Tetrahydrofuran : Buffer ( 350 : 50 : 600 )

Standard solution: Transfer 25 mg of Alprazolam RS, accurately weighed to a

100 ml volumetric flask add 50 ml of methanol, and shake for
15 minutes to dissolve. Dilute with methanol to volume and
mix. Transfer 1 ml of this solution to a 500 ml volumetric flask
and dilute with Buffer solution up to the mark and mix.

Sample
Preparation: Place 500 ml of dissolution medium previously adjust to the
temperature to 37 º + 0.5ºC in six dissolution flask. Put six
tablets individually in the dissolution basket. Then immediately
operate the apparatus. Withdraw the sample from the zone
midway between the surface of the medium and the top of the
blade not less then 1cm from the vessel wall after 30 minutes.
Filter through the filter paper.

Filter both sample & standard preparation through 0.45µ

membrane filter paper. Inject separately equal volume of the
standard & sample into the Chromatograph. Record the
Chromatogram & measure the peak areas for the major peak.

%age of Alprazolam = Peak area of sample x Std Wt x 1 x 500 x 100

Peak area of standard 100 500 0.25

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 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY ASSURANCE SECTION: QUALITY
CONTROL
Subject: Anxiorid 0.25mg tablet Specification ISO SOP No. QC/TAB- 07
Supersedes date: Jan, 2013
SOP No.: Nil
Issue date To be revised on: Revision no. Page 6 of 7
05-01-2018 05-01-2023 01

Assay:
(Alprazolam)

Buffer: Dissolve 0.77gm of ammonium acetate in 1000ml of water and adjust with
acetic acid to a pH of 4.7.

Mobile phase: Take Buffer and Acetonitrile in the ratio 600:400 and mix well, filter
and degas.

Diluent: Acetonitrile : Water (400 : 600)

Chromatographic Conditions:

Column : 4.6 x 15-cm (L7)

Temperature : Ambient
Flow rate : 1ml / min
Wavelength : 260nm
Attenuation : 5 (adjustable)
Inject volume : 20µl

Standard Preparation: Dissolve an accurately 25mg of Alprazolam in 50ml volumetric

Flask, add 30ml diluent and shake for 15 minutes then makeup
volume up to the mark with diluent. Transfer 5ml of this solution to

6
 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY ASSURANCE SECTION: QUALITY
CONTROL
Subject: Anxiorid 0.25mg tablet Specification ISO SOP No. QC/TAB- 07
Supersedes date: Jan, 2013
SOP No.: Nil
Issue date To be revised on: Revision no. Page 7 of 7
05-01-2018 05-01-2023 01

50ml volumetric flask and make up the volume up to the mark with
diluent.

Sample Preparation: Weight 20 Tablets Crush with pestle & mortar. Weigh accurately
equivalent to 2.5mg of Alprazolam in 50ml volumetric flask, add
30ml diluent and shake for 15 minutes then makeup volume up to
the mark with diluent and filter.

Procedure: Filter both sample & standard preparation through 0.45µ

membrane filter paper. Inject separately equal volume of the
standard & sample into the Chromatograph. Record the
Chromatogram & measure the peak areas for the major peak.

Calculation:

Mg/Tablet (Alprazolam) = Peak area of the sample X Wt of Std. X Av. Wt.

Peak area of the standard Wt of Spl

%age of Alprazolam = Mg/Tablet x 100

LC.