VERITAS PHARMACEUTICALS LIMITED,

Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

ffiritas
STANDARD TEST PROCEDURE
Name OPADRY@ Il 85G58921 White

Document No.: TP/1 11 5005/01 lssue Date : 24 Jan2014

Version No.: 0'l Superseded doc. No.: VRME/O/'I 21 1/001 Review Date : 23 Jan 2017

Approval of Current Version of the Document

Name Job Title Siqnature & Date
Prepared by Md. Monjur Rahman Quality Control Officer t,A*";U
9t ./it lll)
Agreed by Md. Tarikul lslam Bossunia Asst. Manager Quality Control
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Approved by Md. Moniruzzaman Quality Assurance Manager +rr-^Ot,l).tV

CONTENT

1. Appearance
2. ldentification
3. Colour difference
4. Ash content, %
5. Dispersion (25% in water)
6. Revision History

DISTRIBUTION LIST

.Recetv.e(.lr-g;i,liaiu;iiqoiiAit:1itlrl'

QC Laboratory 01

This document is Effeciive from the Date of the Approval"

WlTH0UTPERMlSSIoNFRoMHEADoFQUALlTYASSURANcEoRH
DOCUMENT IS STRICTLY PROHIBITED

IF THE DOCUMENT IS SIGNED BY BLUE INK IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR
ROUTINE WORK
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 VERITAS PHARMACEUTICALS LIMITED,
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas
ST ANO ARO TEST PROGEOURE

Material Name: OPADRY@ ll 85G58921 White

Doc. No.: TP/1 1 15005/01 Version: 01 Prepared By: \zt*-<r/, Approved er' ffii. t'
1. Description
Procedure:

Take about 1 gm of sample in a watch glass and observe for its physical appearance, color, etc, using a white background.

Limit: A white powder.

2. ldentification
Procedure:
Sample preparation: Weigh 1 to 2 mg of the sample and weigh 300 to 400 mg of fine dry powder of potassium bromide.
Carefully grind the mixture, spread it uniformly in a suitable die, and submit it to a pressure of about B0 KN. Transfer the disc
into the sample holder cup and record the IR spectrum.

Standard preparation: Weigh 1 to 2 mg of the Opadry White (85G68918) Reference Sample and weigh 300 to 400 mg of
potass\um brom\de. Careiu\ gr\nd the m\xture, spread \t unitorm\y \n a su\\ab\e d\e, and subm\t\t to a pressure of about B0 KN.
Transfer the disc into the sample holder cup and record the lR spectrum.
Acceptance criteria: The infrared absorption spectrum of sample is concordant with the spectrum obtained from Opadry White
(85G6891 B) Reference Sample.

3. Colour Difference
Take about 1 g of sample and 1 g of reference sample in two watch glasses and observe for their color.

Limit: Visually matched to Reference Sample.

4. Ash Content
Dry a weighing crucible in a muffle furnace at 600"C for 30 minutes. Place it in desiccators, allow cooling and weighing.
Accurately weigh about 1.0 g of dried sample in the crucible and ignite it in the furnace. .Rembve the crucible and allow cooling
in desiccators and reweigh. Calculate the ash content using the following formula:
Calculation:
(W1-W2)x100
(w1-c)

Where, C = Weight of the crucible (in g)

W1 = Weight of the crucible and sample before ignition (in g).
W2 = Weight of the crucible and the sample after ignition (in g).

Limit: 40.4 to 54,60% w/w

5. Dispersion

Take 2.5 g of the sample in 10 ml of water and stire the mixture for 10 minutes.

Limit: No undispersed material

6. Revision History

Document No. Version No Date Reason

vRME/O/1211l001 00 Jan2012 lnitial procedure for analysis of Opadry White (B5G6B91B)

TP/1 1 1 5005/01 01 Jan 2014 To detail the procedure for analysis of Opadry White (85G68918)

IF THE DOCUMENT IS SIGNED BY BLUE INI(, IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
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