Actual Withdrwal Vol (V) : STD Area in Case of HPLC

Matrix Laboratories Limited, Nashik UNIT Version No.
: MLL/QC/E/005
Quality Control Department
Title:Excel worksheet Dissolution for multiple sampling intervals
Name of Product Ferric Citrate Tablets

Batch No. TTR1903 AR No. MLN/CVS/114505
Active component Ferric Citrate Potency of WRS 91.30 %
Factor 1.00000 Molecular weight 1 1.000 Molecular weight 2 1.000
Dissolution condition
Medium 900 ml RPM 75.0 Temp. 37.0 °C label claim 40 mg/unit
Std preparation 30.5 mg 50 ml 8.0 ml 100.0 ml 1.0 ml 1.0 ml
Sample preparation 1 unit 900 ml 1 ml 1.0 ml 1.0 ml 1.0 ml
Std area in Case of HPLC 3507376 3506045 3505799 3505751 3506097 3505673 Avg 3506124 SD 636.0231914 RSD in % 0.0
Actual withdrwal vol (V) 10.0 ml
Time in Area/abs of Std Percentage Drug disolved for
minutes Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6 area/abs Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6
10 3236332 3203990 3559256 3462656 3594238 3704858 3542472 91.58 90.67 100.72 97.99 101.71 104.84
15 3891514 3839071 3571839 3514026 3557058 3535658 3542472 110.12 108.64 101.08 99.44 100.66 100.05
20 3470814 3570628 3598132 3546899 3527678 3538099 3542472 98.22 101.04 101.82 100.37 99.83 100.12
30 3551285 3590542 3526026 3470542 3403550 3424644 3542472 100.50 101.61 99.78 98.21 96.32 96.91
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Time in Correction factor Corrected Results

Min Max Avg RSD
minutes Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6 Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6
10 0.00 0.00 0.00 0.00 0.00 0.00 92 91 101 98 102 105 91 105 98 5.8
15 1.02 1.01 1.12 1.09 1.13 1.16 111 110 102 101 102 101 101 111 105 4.5
20 1.22 1.21 1.12 1.10 1.12 1.11 100 103 104 103 102 102 100 104 102 1.3
30 1.09 1.12 1.13 1.12 1.11 1.11 104 105 103 102 100 100 100 105 102 2.0
0 1.12 1.13 1.11 1.09 1.07 1.08 #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
0 #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Calculation Formula:
% drug dissolved= Atn x DS xP x 100 x F % dissolved of previous interval x withdrawal qty Corrected % dissolved + correction factor
Correction Factor= (Tn)
(Dn) AS x DT x 100 Volume of media results = of previous all intervals
Atn= peak are/abs at n time intervals DS=Dsilution factor of standard P=Purity of WRS Note: For first time intervals no correction
As-Average area/abs of standard DT=Dilution factor of sample required
Analysed By Checked By
Date Date
Eskag Pharma Pvt. Ltd., Haridwar
Quality Control Department
Title:Excel worksheet Dissolution for multiple sampling intervals
Name of Product Ferric Citrate Tablets Batch No. EPFC20001
Label claim 210 mg AR No. Eskag Granules sent to algeria Comoressed & Coating at Eskag
Active component Ferric Citrate Potency of WRS 1.00 %
Factor 1.00000 Molecular weight 1 1.000 Molecular weight 2 1.000
Dissolution Medium 0.1 Nn HCl

Dissolution condition
Medium 900 ml RPM 75.0 Temp. 37.0 °C Apparatus Paddle
Std preparation 1 mg 1 ml 1.0 ml 1.0 ml 1.0 ml 1.0 ml
Sample preparation 1 unit 900 ml 1 ml 1.0 ml 1.0 ml 1.0 ml
Actual withdrwal volume 50.0 ml
Time in Titer value of 0.02 M sod Thiosulphate Equivalent Percentage Drug disolved for
Factor
minutes Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6 Factor Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6
5 3.8 4.4 4.1 4.6 4.4 4.9 1.018 1.117 37.04 42.89 39.96 44.83 42.89 47.76
10 7.2 7.5 7.4 7.6 7.4 8 1.018 1.117 70.18 73.10 72.13 74.07 72.13 77.97
15 8.2 8.4 8.4 8.4 8.3 8.5 1.018 1.117 79.92 81.87 81.87 81.87 80.90 82.85
20 8.6 8.7 8.6 8.7 8.7 8.9 1.018 1.117 83.82 84.80 83.82 84.80 84.80 86.74
45 8.5 8.7 8.5 8.9 8.9 9 1.018 1.117 82.85 84.80 82.85 86.74 86.74 87.72
Time in Correction factor Corrected Results

Min Max Avg RSD
minutes Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6 Unit 1 Unit 2 Unit 3 Unit 4 Unit 5 Unit 6
5 0.00 0.00 0.00 0.00 0.00 0.00 37 43 40 45 43 48 37 48 43 8.9
10 2.06 2.38 2.22 2.49 2.38 2.65 72 75 74 77 75 81 72 81 76 4.0
15 3.90 4.06 4.01 4.12 4.01 4.33 86 88 88 88 87 90 86 90 88 1.5
20 4.44 4.55 4.55 4.55 4.49 4.60 94 96 95 96 96 98 94 98 96 1.4
45 4.66 4.71 4.66 4.71 4.71 4.82 98 101 98 103 102 104 98 104 101 2.5
Calculation Formula:
Atn x DS xP x 100 x F % dissolved of previous interval x withdrawal qty Corrected % dissolved + correction factor
% drug dissolved= (Dn) Correction Factor= (Tn)
AS x DT x 100 Volume of media results = of previous all intervals
Atn= peak are/abs at n time intervals DS=Dsilution factor of standard P=Purity of WRS Note: For first time intervals no correction
As-Average area/abs of standard DT=Dilution factor of sample required
Analysed By Checked By
Date Date

Actual Withdrwal Vol (V) : STD Area in Case of HPLC

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Actual Withdrwal Vol (V) : STD Area in Case of HPLC

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Matrix Laboratories Limited, Nashik UNIT Version No.

Name of Product Ferric Citrate Tablets

Time in Correction factor Corrected Results

Name of Product Ferric Citrate Tablets Batch No. EPFC20001

Active component Ferric Citrate Potency of WRS 1.00 %

Factor 1.00000 Molecular weight 1 1.000 Molecular weight 2 1.000

Dissolution Medium 0.1 Nn HCl

Std preparation 1 mg 1 ml 1.0 ml 1.0 ml 1.0 ml 1.0 ml

Sample preparation 1 unit 900 ml 1 ml 1.0 ml 1.0 ml 1.0 ml

Actual withdrwal volume 50.0 ml

Time in Correction factor Corrected Results

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