DAWA Limited

P. O. Box 16633 – 00620

NAIROBI
Stability Studies Report

PRODUCT NAME: DAWACLOX POWDER FOR ORAL SOLUTION

GENERIC NAME: CLOXACILLIN SODIUM POWDER FOR ORAL SOLUTION

DOSAGE FORM AND STRENGTH: Each 5ml contains Cloxacillin (as Sodium) 125mg

PACK SIZE: 100ml

BATCHES PLACED ON STABILITY:

BATCH No. MFG.DATE

TRI – CLOXS 001 10/ 2008
TRI – CLOXS 002 10/2008
TRI – CLOXS 003 10/2008

FULL DESCRIPTION OF THE PRODUCT:

A whitish coloured, free flowing granular powder yields an orange coloured syrup 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 whitish coloured, free flowing granular powder yields an orange coloured syrup on
reconstitution, packed in 100ml amber coloured glass bottles
2 pH 5.0 – 7.5
3 Impurities Must comply with the tests
4 Microbial contamination Must comply with the tests
5 Assay : content of Cloxacillin (as sodium) Initial :90 – 120% Label claim,
After 7 days of reconstitution: 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 Report

DATA SHEET ACCELERATED STABILITY STUDY

Product: DAWACLOX POWDER FOR ORAL SOLUTION

Label Claim: Each 5ml contains Cloxacillin (as Sodium) 125mg
Batch No: TRI – CLOXS 001 Specification No. Quantity of sample/analysis:
SP/FP-DPS/006 - 04 10 x 100 ml
Date of mfg: 10/2008
Date of Exp: xxxxxx
Interval Description: A whitish Initial pH: pH after 7 days Specific Impurities: Assay : Assay stability : Remarks
in coloured, free flowing 5.0 – 7.5 of gravity: Must comply Initial :90 – 120% After 7 days of
Months granular powder reconstitution: 1.05 – 1.25 with the tests Microbial contamination Label claim reconstitution:
yields an orange 5.0 – 7.5 80 – 120% Label
coloured syrup on claim
reconstitution, packed Bacteria: Fungi: P. aeruginosa: E.coli: S. S.spp:
in 100ml amber NMT 1000 NMT 100 must be must be aureus: must be
coloured glass bottles cfu/ml cfu/ml absent absent must be absent
. absent
Initial Complies 6.41 6.28 1.140 Complies Complies Complies Nil Nil Nil Nil 103.77 102.54 Complies

2 Complies 6.52 6.48 1.142 Complies Complies Complies Nil Nil Nil Nil 102.26 101.66 Complies

4 Complies 6.46 6.37 1.148 Complies Complies Complies Nil Nil Nil Nil 102.03 101.60 Complies

6 Complies 6.62 6.53 1.144 Complies Complies Complies Nil Nil Nil Nil 101.41 98.43 Complies

Note: P. aeruginosa - Pseudomonas aeruginosa, E.coli – Escherichia coli, S. aureus - Staphylococcus aureus and S.spp - Salmonella species.

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

DATA SHEET ACCELERATED STABILITY STUDY

Product: DAWACLOX POWDER FOR ORAL SOLUTION

Label Claim: Each 5ml contains Cloxacillin (as Sodium) 125mg
Batch No: TRI – CLOXS 002 Specification No. Quantity of sample/analysis:
SP/FP-DPS/006 - 04 10 x 100 ml
Date of mfg: 10/2008
Date of Exp: xxxxxx
Interval Description: A whitish Initial pH: pH after 7 days Specific Impurities: Assay : Assay stability : Remarks
in coloured, free flowing 5.0 – 7.5 of gravity: Must comply Microbial contamination Initial : After 7 days of
Months granular powder yields an reconstitution: 1.05 – 1.25 with the tests 90 – 120% reconstitution:
orange coloured syrup on 5.0 – 7.5 Label claim 80 – 120% Label
reconstitution, packed in Bacteria: Fungi: P. aeruginosa: E.coli: S. S.spp: claim
100ml amber coloured glass NMT 1000 NMT 100 must be absent must be aureus: must be
bottles . cfu/ml cfu/ml absent must be absent
absent
Initial Complies 6.53 6.46 1.140 Complies Complies Complies Nil Nil Nil Nil 103.89 102.54 Complies

2 Complies 6.61 6.57 1.142 Complies Complies Complies Nil Nil Nil Nil 102.51 101.45 Complies

4 Complies 6.48 6.39 1.148 Complies Complies Complies Nil Nil Nil Nil 102.03 101.08 Complies

6 Complies 6.37 6.28 1.144 Complies Complies Complies Nil Nil Nil Nil 100.47 99.63 Complies

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

DATA SHEET ACCELERATED STABILITY STUDY

Product: DAWACLOX POWDER FOR ORAL SOLUTION

Label Claim: Each 5ml contains Cloxacillin (as Sodium) 125mg
Batch No: TRI – CLOXS 003 Specification No. Quantity of sample/analysis:
SP/FP-DPS/006 - 04 10 x 100 ml
Date of mfg: 10/2008
Date of Exp: xxxxxx
Interval Description: A whitish coloured, Initial pH: pH after 7 days Specific Impurities: Assay : Assay stability Remarks
in free flowing granular powder yields 5.0 – 7.5 of gravity: Must comply Microbial contamination Initial : :
Months an orange coloured syrup on reconstitution: 1.05 – 1.25 with the tests 90 – 120% After 7 days of
reconstitution, packed in 100ml 5.0 – 7.5 Bacteria: Fungi: P. aeruginosa: E.coli: S. S.spp: Label claim reconstitution:
amber coloured glass bottles . NMT 1000 NMT 100 must be must be aureus: must be 80 – 120%
cfu/ml cfu/ml absent absent must be absent Label claim
absent
Initial Complies 6.46 6.37 1.140 Complies Complies Complies Nil Nil Nil Nil 101.92 100.07 Complies

2 Complies 6.53 6.49 1.142 Complies Complies Complies Nil Nil Nil Nil 101.65 100.02 Complies

4 Complies 6.66 6.58 1.148 Complies Complies Complies Nil Nil Nil Nil 100.47 99.27 Complies

6 Complies 6.42 6.36 1.144 Complies Complies Complies Nil Nil Nil Nil 100.33 98.30 Complies

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

DATA SHEET REAL TIME STABILITY STUDY

Product: DAWACLOX POWDER FOR ORAL SOLUTION

Label Claim: Each 5ml contains Cloxacillin (as Sodium) 125mg
Batch No: TRI – CLOXS 001 Specification No. Quantity of sample/analysis:
SP/FP-DPS/006 - 04 10 x 100 ml
Date of mfg: 10/2008
Date of Exp: xxxxxx
Interval Description: A whitish Initial pH: pH after 7 days Specific Impurities: Assay : Assay stability Remarks
in coloured, free flowing 5.0 – 7.5 of gravity: Must comply Microbial contamination Initial : :
Months granular powder yields reconstitution: 1.05 – 1.25 with the tests Bacteria: Fungi: P. aeruginosa: E.coli: S. S.spp: 90 – 120% After 7 days of
an orange coloured syrup 5.0 – 7.5 NMT 1000 NMT 100 must be must be aureus: must must be Label claim reconstitution:
on reconstitution, packed cfu/ml cfu/ml absent absent be absent absent 80 – 120%
in 100ml amber coloured Label claim
glass bottles .
Initial Complies 6.41 6.28 1.140 Complies Complies Complies Nil Nil Nil Nil 103.77 102.54 Complies

3 Complies 6.47 6.38 1.147 Complies Complies Complies Nil Nil Nil Nil 102.26 100.31 Complies

6 Complies 6.48 6.41 1.145 Complies Complies Complies Nil Nil Nil Nil 102.03 100.27 Complies

9 Complies 6.33 6.25 1.141 Complies Complies Complies Nil Nil Nil Nil 101.41 99.67 Complies

12 Complies 6.26 6.18 1.148 Complies Complies Complies Nil Nil Nil Nil 100.98 98.98 Complies

18 Complies 6.44 6.36 1.145 Complies Complies Complies Nil Nil Nil Nil 100.65 98.65 Complies

24 Complies 6.39 6.32 1.143 Complies Complies Complies Nil Nil Nil Nil 100.08 97.98 Complies

36 Complies 6.28 6.16 1.141 Complies Complies Complies Nil Nil Nil Nil 99.82 97.61 Complies

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

DATA SHEET REAL TIME STABILITY STUDY

Product: DAWACLOX POWDER FOR ORAL SOLUTION

Label Claim: Each 5ml contains Cloxacillin (as Sodium) 125mg
Batch No: TRI – CLOXS 002 Specification No. Quantity of sample/analysis:
SP/FP-DPS/006 - 04 10 x 100 ml
Date of mfg: 10/2008
Date of Exp: xxxxxx
Interval Description: A whitish Initial pH: pH after 7 Specific Impurities: Assay : Assay stability Remarks
in coloured, free flowing 5.0 – 7.5 days of gravity: Must comply Microbial contamination Initial : :
Months granular powder yields reconstitu 1.05 – 1.25 with the tests 90 – 120% After 7 days of
Bacteria: Fungi: NMT P. aeruginosa: E.coli: S. S.spp:
an orange coloured syrup tion: Label claim reconstitution:
NMT 1000 100 cfu/ml must be absent must be aureus: must be
on reconstitution, packed 5.0 – 7.5 80 – 120%
cfu/ml absent must be absent
in 100ml amber coloured Label claim
absent
glass bottles .
Initial Complies 6.53 6.46 1.140 Complies Complies Complies Nil Nil Nil Nil 103.89 102.54 Complies

3 Complies 6.44 6.36 1.147 Complies Complies Complies Nil Nil Nil Nil 103.94 102.30 Complies

6 Complies 6.42 6.35 1.145 Complies Complies Complies Nil Nil Nil Nil 103.91 100.98 Complies

9 Complies 6.38 6.31 1.141 Complies Complies Complies Nil Nil Nil Nil 102.70 100.67 Complies

12 Complies 6.36 6.28 1.148 Complies Complies Complies Nil Nil Nil Nil 102.02 100.34 Complies

18 Complies 6.45 6.36 1.145 Complies Complies Complies Nil Nil Nil Nil 100.40 99.82 Complies

24 Complies 6.48 6.39 1.143 Complies Complies Complies Nil Nil Nil Nil 97.97 97.30 Complies

36 Complies 6.52 6.46 1.141 Complies Complies Complies Nil Nil Nil Nil 97.68 96.27 Complies

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

DATA SHEET REAL TIME STABILITY STUDY

Product: DAWACLOX POWDER FOR ORAL SOLUTION

Label Claim: Each 5ml contains Cloxacillin (as Sodium) 125mg
Batch No: TRI – CLOXS 003 Specification No. Quantity of sample/analysis:
SP/FP-DPS/006 - 04 10 x 100 ml
Date of mfg: 10/2008
Date of Exp: xxxxxx
Interval Description: A whitish Initial pH: pH after 7 days Specific gravity: Impurities: Assay : Assay stability Remarks
in coloured, free flowing 5.0 – 7.5 of 1.05 – 1.25 Must comply Initial : :
Months granular powder yields an reconstitution: with the tests Microbial contamination 90 – 120% After 7 days of
orange coloured syrup on 5.0 – 7.5 Label claim reconstitution:
reconstitution, packed in 80 – 120%
100ml amber coloured Bacteria: Fungi: P. E.coli: S. S.spp: Label claim
glass bottles . NMT 1000 NMT 100 aeruginos must be aureus: must be
cfu/ml cfu/ml a: must absent must be absent
be absent absent
Initial Complies 6.46 6.37 1.140 Complies Complies Complies Nil Nil Nil Nil 101.92 100.07 Complies

3 Complies 6.39 6.31 1.147 Complies Complies Complies Nil Nil Nil Nil 103.94 102.30 Complies

6 Complies 6.42 6.37 1.145 Complies Complies Complies Nil Nil Nil Nil 103.91 100.98 Complies

9 Complies 6.41 6.35 1.141 Complies Complies Complies Nil Nil Nil Nil 102.70 100.67 Complies

12 Complies 6.26 6.19 1.148 Complies Complies Complies Nil Nil Nil Nil 102.02 100.34 Complies

18 Complies 6.38 6.29 1.145 Complies Complies Complies Nil Nil Nil Nil 100.40 99.82 Complies

24 Complies 6.51 6.46 1.143 Complies Complies Complies Nil Nil Nil Nil 97.97 97.30 Complies

36 Complies 6.46 6.37 1.141 Complies Complies Complies Nil Nil Nil Nil 97.68 96.27 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 DAWACLOX POWDER FOR ORAL
SOLUTION.
 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 DAWACLOX POWDER FOR
ORAL SOLUTION.

On all packing, the following storage instructions are printed:

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

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