DAWA Limited

P. O. Box 16633 – 00620

NAIROBI
Stability Studies

PROTOCOL

PRODUCT NAME: ERYTHROX 125 MG DRY SUSPENSION

GENERIC NAME: ERYTHROMYCIN POWDER FOR ORAL SUSPENSION

DOSAGE FORM AND STRENGTH: Each 5ml contains Erythromycin (as Stearate) 125mg

PACK SIZE: 100ml

BATCHES PLACED ON STABILITY:

BATCH No. MFG.DATE

TRI-ERDPS001 03/ 2009
TRI-ERDPS002 03/2009
TRI-ERDPS003 03/2009

FULL DESCRIPTION OF THE PRODUCT:

A pinkish coloured, free flowing granular powder, yields a pink coloured suspension on reconstitution, packed in 100ml amber
coloured glass bottles .

STORAGE CONDITIONS OF STUDY:

Accelerated Stability Studies Real Time Stability Studies

Temperature 400 C ± 20 C 300 C ± 20 C
Humidity 75%  5 % RH 65%  5 % RH
Time intervals of study( months) 0, 2, 4 and 6 0, 3, 6, 9, 12, 18 ,24 and 36

TESTS TO BE PERFORMED THROUGHOUT STUDY:

SR.No. TESTS SPECIFICATIONS

1 Description A pinkish coloured, free flowing granular powder, yields a pink
coloured suspension on reconstitution
2 pH 6.5 – 9.5
3 Specific gravity 1.00 – 1.20
4 Assay: content of
Erythromycin ( as Stearate ) Initial :90 – 120% , After 7 days: 80 – 120% Label claim

REASON FOR STABILITY TESTING: Shelf life determination

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 DAWA Limited
P. O. Box 16633 – 00620
NAIROBI
Stability Studies

Protocol Data Sheet ACCELERATED STABILITY STUDY

Product: ERYTHROX 125 MG DRY SUSPENSION

Label Claim: Each 5ml contains Erythromycin (as Stearate) 125mg
Batch No: TRI-ERDPS001 Specification No. Quantity of sample/analysis:
SP/FP-DPS/010 - 02 10 x100 ml
Date of mfg: 03/ 2009
Date of Exp: xxxxxx
Interval in Description: A pinkish coloured, pH: Specific gravity: Initial Assay :90 – 120% Label Assay stability : After 7 days: Remarks
Months free flowing granular powder, yields 6.5 – 9.5 1.00 – 1.20 claim 80 – 120% Label claim
a pink coloured suspension on
reconstitution
Initial Complies 8.35 1.120 112.23 109.75 Complies
2 Complies 8.47 1.132 108.22 103.44 Complies
4 Complies 8.60 1.148 103.26 99.58 Complies
6 Complies 8.71 1.154 100.11 96.78 Complies

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Page 2 of 8
 DAWA Limited
P. O. Box 16633 – 00620
NAIROBI
Stability Studies

Protocol Data Sheet ACCELERATED STABILITY STUDY

Product: ERYTHROX 125 MG DRY SUSPENSION

Label Claim: Each 5ml contains Erythromycin (as Stearate) 125mg
Batch No: TRI-ERDPS002 Specification No. Quantity of sample/analysis:
SP/FP-DPS/010 - 02 10 x100 ml
Date of mfg: 03/ 2009
Date of Exp: xxxxxx
Interval in Description: A pinkish coloured, free flowing pH: Specific gravity: Initial Assay :90 – 120% Assay stability : After 7 days: Remarks
Months granular powder, yields a pink coloured 6.5 – 9.5 1.00 – 1.20 Label claim 80 – 120% Label claim
suspension on reconstitution
Initial Complies 8.40 1.127 116.23 113.45 Complies
2 Complies 8.55 1.136 111.85 108.56 Complies
4 Complies 8.64 1.144 106.25 103.45 Complies
6 Complies 8.80 1.152 102.55 99.68 Complies

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Page 3 of 8
 DAWA Limited
P. O. Box 16633 – 00620
NAIROBI
Stability Studies

Protocol Data Sheet ACCELERATED STABILITY STUDY

Product: ERYTHROX 125 MG DRY SUSPENSION

Label Claim: Each 5ml contains Erythromycin (as Stearate) 125mg
Batch No: TRI-ERDPS003 Specification No. Quantity of sample/analysis:
SP/FP-DPS/010 - 02 10 x100 ml
Date of mfg: 03/ 2009
Date of Exp: xxxxxx
Interval in Description: A pinkish coloured, free flowing pH: Specific gravity: Initial Assay :90 – 120% Assay stability : After 7 days: Remarks
Months granular powder, yields a pink coloured 6.5 – 9.5 1.00 – 1.20 Label claim 80 – 120% Label claim
suspension on reconstitution
Initial Complies 8.33 1.120 117.12 104.74 Complies
2 Complies 8.48 1.132 114.22 101.47 Complies
4 Complies 8.55 1.148 111.76 108.26 Complies
6 Complies 8.72 1.153 108.63 106.27 Complies

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Page 4 of 8
 DAWA Limited
P. O. Box 16633 – 00620
NAIROBI
Stability Studies

Protocol Data Sheet REAL TIME STABILITY STUDY

Product: ERYTHROX 125 MG DRY SUSPENSION

Label Claim: Each 5ml contains Erythromycin (as Stearate) 125mg
Batch No: TRI-ERDPS001 Specification No. Quantity of sample/analysis:
SP/FP-DPS/010 - 02 10 x100 ml
Date of mfg: 03/ 2009
Date of Exp: xxxxxx
Interval in Description: A pinkish coloured, free flowing pH: Specific gravity: Initial Assay :90 – 120% Assay stability : After 7 days: Remarks
Months granular powder, yields a pink coloured 6.5 – 9.5 1.00 – 1.20 Label claim 80 – 120% Label claim
suspension on reconstitution
Initial Complies 8.35 1.120 112.23 109.75 Complies
3 Complies 8.48 1.130 110.63 107.77 Complies
6 Complies 8.58 1.141 106.72 103.99 Complies
9 Complies 8.60 1.150 104.46 101.43 Complies
12 Complies 8.72 1.169 101.23 98.28 Complies
18 Complies 8.97 1.176 98.79 95.79 Complies
24 Complies 9.11 1.189 96.48 93.42 Complies
36 Complies 9.28 1.193 94.85 91.66 Complies

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Page 5 of 8
 DAWA Limited
P. O. Box 16633 – 00620
NAIROBI
Stability Studies

Protocol Data Sheet REAL TIME STABILITY STUDY

Product: ERYTHROX 125 MG DRY SUSPENSION

Label Claim: Each 5ml contains Erythromycin (as Stearate) 125mg
Batch No: TRI-ERDPS002 Specification No. Quantity of sample/analysis:
SP/FP-DPS/010 - 02 10 x100 ml
Date of mfg: 03/ 2009
Date of Exp: xxxxxx
Interval in Description: A pinkish coloured, free flowing pH: Specific gravity: Initial Assay :90 – 120% Assay stability : After 7 days: Remarks
Months granular powder, yields a pink coloured 6.5 – 9.5 1.00 – 1.20 Label claim 80 – 120% Label claim
suspension on reconstitution
Initial Complies 8.40 1.127 116.23 113.45 Complies
3 Complies 8.48 1.132 112.47 110.26 Complies
6 Complies 8.56 1.148 100.87 97.47 Complies
9 Complies 8.67 1.155 98.49 96.46 Complies
12 Complies 8.73 1.162 97.44 95.92 Complies
18 Complies 8.94 1.179 96.25 94.12 Complies
24 Complies 9.17 1.186 94.75 92.88 Complies
36 Complies 9.33 1.197 91.59 90.34 Complies

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Page 6 of 8
 DAWA Limited
P. O. Box 16633 – 00620
NAIROBI
Stability Studies

Protocol Data Sheet REAL TIME STABILITY STUDY

Product: ERYTHROX 125 MG DRY SUSPENSION

Label Claim: Each 5ml contains Erythromycin (as Stearate) 125mg
Batch No: TRI-ERDPS003 Specification No. Quantity of sample/analysis:
SP/FP-DPS/010 - 02 10 x100 ml
Date of mfg: 03/ 2009
Date of Exp: xxxxxx
Interval in Description: A pinkish coloured, free flowing pH: Specific gravity: Initial Assay :90 – 120% Assay stability : After 7 days: Remarks
Months granular powder, yields a pink coloured 6.5 – 9.5 1.00 – 1.20 Label claim 80 – 120% Label claim
suspension on reconstitution
Initial Complies 8.33 1.120 117.12 114.74 Complies
3 Complies 8.57 1.137 114.46 111.47 Complies
6 Complies 8.62 1.142 109.45 105.66 Complies
9 Complies 8.78 1.155 105.36 103.76 Complies
12 Complies 8.89 1.169 102.86 100.88 Complies
18 Complies 8.95 1.172 100.46 97.89 Complies
24 Complies 9.21 1.184 97.45 95.43 Complies
36 Complies 9.38 1.192 95.13 93.11 Complies

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Page 7 of 8
 DAWA Limited
P. O. Box 16633 – 00620
NAIROBI
Stability Studies

SUMMARY AT END OF COMPLETED STUDY

Summary of the results

The results of the stability tests show that the primary package is suitable for the long term storage of the product
ERYTHROX 125 MG DRY SUSPENSION.
 The physical parameters assessed during this study did not change the characteristics of the product under
storage.
 The active ingredient remained within the established limits when stored under the same conditions.
Conclusion
Based on the stability data obtained over a period of up to 36 months, a shelf life of 3 years can be presumed for the
preparation ERYTHROX 125 MG DRY SUSPENSION.

On all packing, the following storage instructions are printed:

Store in a dry place, below 300 C protected from light

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