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apex Plant – II, Alathur No.: TDS: RME0013

RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

Batch No.: Mfr: GRN No.:

Test Started on: Sup: Qty. Received:
Test Completed on: Mfg.Date: Exp.Date: No. of Cont.:
S.No TEST SPECIFICATION
A White or yellowish-white powder or
1.0 Description* flakes, odourless or almost
odourless,hygroscopic..
Freely soluble in water, ethanol
2.0 Solubility (95.0%) and Chloroform, Practically
in soluble in ether.
3.0 Identification:* First Identification: A and D
Second Identification: B,Cand D
Concordant with the reference
Test A: IR Spectrum spectrum of Povidone.
Test B, C&D: Chemical
Should comply
reaction
4.0 Appearance of Solution:* Should comply

5.0 Heavy metals Not more than 10 ppm

6.0 Aldehydes Not more than 9.1 ml

7.0 Vinyl pyrrolidone Not more than 3.6 ml

8.0 Sulphated ash Not more than 0.1% w/w

9.0 Water* Not more than 5.0%w/w

Viscosity (expressed as K-
10.0
value)

11.0 Assay* (nitrogen content) 11.5 % to 12.8 % w/w

* Tests to be performed on Retesting.

Remarks: The sample Complies / Does not comply with the specification.
Analyzed by Checked by Head-QC
Sign: Sign: The material is Approved/Not Approved for use.

Date: Date: Sign: Date:

Prepared by: Reviewed by: Approved by: Usage copy- Issued by:
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Date: Date: Date: Date:
 apex laboratories private limited Page 2 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

3.0 Identification: Test B. Infrared Spectrophotometry for Sign& date:

samples from individual containers: Instrument code:

The IR Spectrum ______________________with the reference spectrum of Povidone RS

Tested for individual containers:

Cont. Cont. Cont. Sign
No. Remarks Sign No. Remarks Sign No. Remarks

1.0 Description: Sign & Date:

Checked By: Date:

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Sign: Sign: Sign: Sign:
Date: Date: Date: Date:
 apex laboratories private limited Page 3 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

_______________________________________________________________________________

_______________________________________________________________________________
Observation: Complies / Does not comply

2.0 Solubility: Instrument Code: Sign & Date:

S.No Gross Wt. Tare Wt. Net Wt.

1
2
3
4

Procedure Observation Result

__________(1.0 g) of sample +
________(1ml )of water
Added further_______( 9ml) of
water in portions.
__________(1.0 g) of sample +
__________(1ml )of
ethanol( (B.No:__________)
Added further________( 9ml) of
ethanol in portions.
( B.No:____________)
__________(1.0g) of sample +
_________(1ml )of Chloroform
(B.No:____________).
Added further_______( 9ml) of
Chloroform in portions.
( B.No:__________)
__________(10 mg )of sample +
_________(100 ml )of ether.
( B.No____________)

3.0 Identification: Instrument code: Sign & Date:

Test A: By FTIR:

The IR spectrum of the sample __________________ with the reference spectrum of Povidone.

Test B: Instrument Code: Sign & Date:

Checked By: Date:

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Sign: Sign: Sign: Sign:
Date: Date: Date: Date:
 apex laboratories private limited Page 4 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

Added _______( 2.5g) to a suitable volume of water, stirred with a magnetic stirrer, and diluted
to ______(25 ml ) with the same solvent (solution A). To ______(0.4 ml) of solution A added
____(10 ml) of water, ______(5 ml) of 2M hydrochloric acid (B.No.:________).and ____( 2 ml) of
potassium dichromate solution(B.No.:________).

Observation:_________________________________ Complies /Does not comply

Test C : To _____( 1 ml) of solution A added _____(0.2 ml) of dimethylaminobenzaldehyde

reagent(B.No.:________). and _____(0.1 ml) of sulphuric acid (B.No.:________).

Observation:_________________________________ Complies / Does not comply

Test D : To ______(0.1ml) of solution A added ______(5 ml) of water and ____(0.2 ml) of 0.05M
iodine(B.No.:________).

Observation:_________________________________ Complies / Does not comply

4.0 Appearance of solution: Instrument Code: Sign & Date:

Sample : Gr.Wt:____________ Tr.Wt.:____________ Nt.Wt.:_____________

Solution A: Dissolved ___________ g of sample in carbon dioxide-free water and diluted to ___ml
with the same solvent.

Solution A is _________ and ___________________ coloured than reference solution BS6-

(B.No.:________) and BYS6 (B.No.:________).

5.0 Heavy Metals : Instrument Code: Sign & Date:

Sample: Gr.Wt:___________ Tr.Wt.:____________ Nt.Wt.:___________
Test solution: Mixed thoroughly _______( 2.0g )of the sample in a silica crucible with ______
(0.5g) of magnesium oxide. Ignited to dull red until a ____________________________ is
produced. Heated at _______(800 °C) for about ____(1 hour). The residue is taken up in 2
quantities, added_____(5ml) of 5 M hydrochloric acid and added ____(0.1 ml) of phenolphthalein
solution (B.No.:__________ ) and then strong ammonia( B.No:_________) until a pink colour is
obtained. Cooled, added glacial acetic acid( B.No:__________) until the solution is decolorised
and added ______(0.5 ml) in excess. Diluted to ______ ( 20ml )with water.

Reference solution (standard): To ____(2ml) of lead standard solution (10 ppm Pb)-
(B.No.:__________ ) instead of the sample and drying in oven at _____ °C. To ___ (10 ml) of the
Checked By: Date:

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Sign: Sign: Sign: Sign:
Date: Date: Date: Date:
 apex laboratories private limited Page 5 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

solution obtained added ______(2ml) of the test solution.

Blank solution: A mixture of _____(10 ml) of water and _____(2 ml) test solution used.

Procedure: To ____(12 ml )of each solution, added _____(2 ml) of buffer solution pH 3.5.
(B.No.:_______) Mixed. Added _____(1.2 ml) of thioacetamide reagent
(B.No.:__________ ). Mixed immediately. Examined the solutions after_____(2 minutes).

Observation:____________________________________________________________________
__

Complies / Does not comply

6.0 Aldehydes: Instrument code: Sign & date:

Sample: Gr.Wt:___________ Tr.Wt.:____________ Nt.Wt.:___________

Boiled ______(20.0 g )in _____(180 ml) of a 25% v/v solution of sulphuric

acid(B.No.:_________) in a ground-glass-stoppered flask under a reflux condenser for ______
(45minutes) and allowed to cool. Fitted a distillation head, distilled and collected ______(60 ml)of
the distillate in _____(20 ml)
of a 7.0% w/v solution of hydroxylamine hydrochloride(B.No.:__________ )., previously adjusted
to pH 3.1 using 1M sodium hydroxide(B.No.:__________ )., and cooled in ice. Titrated with 0.1M
sodium hydroxide(B.No.:__________ ). to pH 3.1.

Performed a blank determination.

Observation: ______ ml of 0.1M sodium hydroxide is required. Limit: NMT 9.1ml(0.2%)

Complies / Does not comply.
7.0 Vinylpyrrolidone: Instrument code: Sign & date:

Sample: Gr.Wt:___________ Tr.Wt.:____________ Nt.Wt.:___________

Checked By: Date:

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Sign: Sign: Sign: Sign:
Date: Date: Date: Date:
 apex laboratories private limited Page 6 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

Test solution:
Dissolved ______(10.0g) in ______(80 ml )of water and added ______(1 g) of   sodium
acetate(B.No:___________) Titrated with 0.05M iodine(B.No.:__________ ) until a persistent
colour is obtained and added a further ______(3.0ml )of the iodine solution( B.No:___________).
Allowed to stand for ______(10 minutes) and titrated the excess of iodine with 0.1M sodium
thiosulphate (B.No.:__________ ) using ______(3 ml) of starch solution(B.No.:__________ ),
added towards the end of the titration, as indicator.
Repeated the operation without the substance being examined using the same total volume of
0.05M iodine. The difference between the titrations represents the amount of iodine consumed by
the vinylpyrrolidone monomer that may be present.
Observation : ______ml of 0.05M iodine is required ( Limit: Not more than 3.6 ml )

Complies / Does not comply

8.0 Sulphated Ash: Instrument code: Sign & date:

Sample: Gr.Wt:___________ Tr.Wt.:____________ Nt.Wt.:___________

Initial Ignition of the empty crucible: _______°C for ______minutes. Cooled and weighed.

Wt. of Empty Crucible Residue + Crucible (2nd)

Wt. of Crucible + Sample Residue + Crucible (3rd)
Wt. of Sample taken Wt. of Empty Crucible
Residue + crucible (1st) Weight of Residue

Final Ignition at Temperature:________

Variation for 1st & 2nd weights =_____ Variation for 2nd & 3rd weights =_____

Calculation:

=>--------------------------------------- = ________ % w/w Limit: NMT 0.1%w/w

Complies/ Does not comply

Checked By: Date:

Prepared by: Reviewed by: Approved by: Usage copy- Issued by:
Sign: Sign: Sign: Sign:
Date: Date: Date: Date:
 apex laboratories private limited Page 7 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

9.0 Water: Instrument code: Sign& date:

Standardization of KF Reagent:

KFR Lot/Batch No.:_______________ Make:______________

Weight of water:

1 2 3
Initial Wt.
Final Wt.
Wt. of water used
Vol.of KFR Consumed
Factor
Precision Limit: NMT 0.2%
Average Factor Limit: NLT 3.5

Sample: Gr.Wt:_______ Tr.Wt.:_______ Nt.Wt.:________ Titre Value:_____

=>--------------------------------------- = ________ % w/w Limit: NMT 5.0%w/w

Complies/ Does not comply

10.0 K-Value: Instrument code: Sign & date:

Sample: Gr.Wt:___________ Tr.Wt.:____________ Nt.Wt.:___________

Dissolved __________ g of sample in _____ ml of water. Allowed to stand for ___ hour and
determined the viscosity of the solution at ____ °C, using viscometer No.1.

Flow time for sample = ______seconds.

Flow time for water = ______ seconds.

Viscosity of sample (z) = ________

Concentration of the sample (c) = ________ x ( 100 – ) = ___________ g/100ml

Checked By: Date:

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 apex laboratories private limited Page 8 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

100

 K-Value - Formula:

Calculation:

-------------------------------------------------------------

-------------------------------------------------------------

Calculation:
-------------------------------------------------------

-------------------------------------------------------

-------------------------------------------------------

-------------------------------------------------------

K-Value = ___________ Limit : 27.0 to 32.1

11.0 Nitrogen: Instrument codes:_____________ Sign & Date:

Sample Weight:

Sple. No Gross wt. Tare wt. Net wt.

1.
2.

Checked By: Date:

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 apex laboratories private limited Page 9 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
Review Period:
Specification & Test Procedure Number: RST: RME0013 A.R.No:

Sample:1
Placed _______(0.3 g) of the substance in to a 200-ml long-necked flask and added
______(1.0g )of a powdered mixture of 10 parts of anhydrous sodium sulphate/ potassium sulphate
( B.No:__________)and 1 part of cupric sulphate( B.No:___________). Added ______ (11ml )of
nitrogen-free sulphuric acid( B.No:____________), For complete destruction of organic matter,
added hydrogen peroxide( B.No:_________) of 10 vol of until a clear,light green solution is
obtained, then heat for further_____( 4) hours. Cooled, carefully added ______ ( 20ml )of water,
cooled again and connected the flask to a distillation apparatus. Added ______(50 ml) of 10M
sodium hydroxide(B.No.:__________ ) and distilled immediately by passing steam through the
flask. Collected the distillate in ______( 25ml) of 0.1 M hydrochloric acid(B.No.:__________ )
and titrated the excess of acid with 0.1 M sodium hydroxide(B.No.:__________ ) using methyl
red-methylene blue solution(B.No.:__________ ) as indicator.
Sample:2
Placed ________(0.3 g) of the substance in to a 200-ml long-necked flask and added ______(1.0g)
of a powdered mixture of 10 parts of anhydrous sodium sulphate/ potassium sulphate
( B.No:__________) and 1 part of cupric sulphate( B.No:___________). Added ______ (11ml )of
nitrogen-free sulphuric acid( B.No:____________), For complete destruction of organic matter,
added hydrogen peroxide( B.No:_________) of 10 vol of until a clear, light green solution is
obtained, then heat for further_____( 4) hours. Cooled, carefully added ______ ( 20ml )of water,
cooled again and connected the flask to a distillation apparatus. Added ______ ( 50ml )of 10M
sodium hydroxide(B.No.:__________ ) and distilled immediately by passing steam through the
flask. Collected the distillate in ______(25ml )of 0.1 M hydrochloric acid(B.No.:__________ )
and titrated the excess of acid with 0.1 M sodium hydroxide(B.No.:__________ ) using methyl
red-methylene blue solution(B.No.:__________ ) as indicator.

Blank:

Sample weight : Gr.Wt:_______ Tr.Wt.:_______ Nt.Wt.:________

Repeated the test using ___________ (0.025mg) of anhydrous dextrose in place of the substance to
be examined

The difference between the titrations represents the ammonia liberated by the substance being
examined.

Each ml of 0.1M hydrochloric acid is equivalent to 0.001401 g of N.

1) -------------------------------------------------- = _________ %w/w

Checked By: Date:

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 apex laboratories private limited Page 10 of 10
apex Plant – II, Alathur No.: TDS: RME0013
RAW MATERIAL TEST DATA SHEET Mat. Code: RME0013
Revision No:01
Material: POVIDONE IP Effective Date:
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Specification & Test Procedure Number: RST: RME0013 A.R.No:

2) -------------------------------------------------- = __________ %w/w

Blank: 1)______ml 2)________ml

Variation for duplicate results: =_____________

(Limit: NMT1.0%)

Average assay:__________ (Limit: 11.5 % to 12.8 % w/w)

APPROVED BY:
Sign: Date:

Checked By: Date:

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