STANDARD OPERATING PROCEDURE

MEDICRAFT PHARMA (PVT) LTD. PESHAWAR

DEPARTMENT: QUALITY CONTROL SECTION: QUALITY
CONTROL
Subject: Bromed 3mg tablet Specification ISO SOP No. QC/TAB- 17
Supersedes date: NIL
SOP No.: NIL
Issue date To be revised on: Revision no. Page 1 of 5
05-01-2018 05-01-2023 03
Written/Revised by: Checked by: Approved by: Authorized by:

Sign. Sign. Sign. Sign.

Name Taimur Rehman Name Fawad Javed Name Irfan Ali Name M.Abdullah
Desig. QC Analyst Desig. Sr.QC Analyst Desig. Asst: QC Manager Desig. QC Manager

1.SHELF LIFE SPECIFICATION:

a)Description: Pink color granular powder

b)Uniformity of Dosage Unit: Meet USP Requirments

c)Avg.weight: 176mg

e) Assay 3 mg / Tablet
(Bromazepam)
(90%---110%)
 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY CONTROL SECTION: QUALITY
CONTROL
Subject: Bromed 3mg tablet Specification ISO SOP No. QC/TAB- 17
Supersedes date: NIL
SOP No.: NIL
Issue date To be revised on: Revision no. Page 2 of 5
05-01-2018 05-01-2023 03

Product Specification:

a) Monograph
Reference: USP 24 / BP 1998

b) Description: Pink color granular powder

c) Av. weight of 176mg

(167.2 – 184.8mg)

d) Thickness: 3.6 – 4.2mm

e) Hardness: NLT 3 kg/ cm2 (tentative)

f) Friability: NMT1%

g) Dosage Uniformity: Meets USP Requirement

h) Disintegration time: NMT 15 minutes

i) Assay 3 mg / Tablet
Bromazepam
(90%---110%)

2
 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY CONTROL SECTION: QUALITY
CONTROL
Subject: Bromed 3mg tablet Specification ISO SOP No. QC/TAB- 17
Supersedes date: NIL
SOP No.: NIL
Issue date To be revised on: Revision no. Page 3 of 5
05-01-2018 05-01-2023 03

Test Methods:

Description: Visually examines a representative number of tablets for

colour, shape marking 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 tablet in each of the six tubes of the basket add 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.

Assay: Method (HPLC)

Reagent :
1. Acetonitrile (HPLC)
2. Methanol (HPLC)
3. Potassium Dihydrogen Phosphate (HPLC)
4.
Mobile Phase: Mix 5 volume of Acetonitrile, 45volume of methanol and 50 volumes of
11.33gm/lit Solution of potassium dihydrogen phosphate previously adjusted to PH 7.0 with a
100g/lit Solution of Potassium Hydroxide Filter & Sonicate.

3
 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY CONTROL SECTION: QUALITY
CONTROL
Subject: Bromed 3mg tablet Specification ISO SOP No. QC/TAB- 17
Supersedes date: NIL
SOP No.: NIL
Issue date To be revised on: Revision no. Page 4 of 5
05-01-2018 05-01-2023 03

Chromatographic Conditions:
Column : 4.6 x 250cm (Intertsil ODS-2) (5µ)
Temperature : 50°C
Flow rate : 1.5ml / min
Wavelength : 235nm
Attenuation : 8 (adjustable)
Inject volume: 20µl

Standard Preparation : Dissolve 20mg bromazepam Working Standard in 100ml

volumetric flask add 50ml mobile phase and shake for 15
minutes. Then make up the volume upto 100ml with Mobile
phase. Filter through 0.45μm filter paper.

Sample Preparation
: Weigh 20 Tabs Crush with pastle & mortor. Take powder eq.
20mg bromazepam in 100ml volumetric flask add 50ml mobile
phase and shake for 15 minutes. Then make up the volume
upto 100ml with Mobile phase. Filter through 0.45μm filter
paper.

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:
Bromazepam mg /Tab = Peak area of Sample x Wt. of Std. x Av. Wt
Peak area of Standard Wt. of Spl
4
 STANDARD OPERATING PROCEDURE
MEDICRAFT PHARMA (PVT) LTD. PESHAWAR
DEPARTMENT: QUALITY CONTROL SECTION: QUALITY
CONTROL
Subject: Bromed 3mg tablet Specification ISO SOP No. QC/TAB- 17
Supersedes date: NIL
SOP No.: NIL
Issue date To be revised on: Revision no. Page 5 of 5
05-01-2018 05-01-2023 03

% age Bromazepam = Mg/Tab x 100

LC