S.7.

1 Stability summary and conclusions

Accelerated Stability:
Accelerated stability studies are initiated with samples from six manufacturing batches. The
samples are packed in small HDPE drums, the samples are kept in an environment chamber.
The temperature and relative humidity in the chamber are maintained at 402 oC and 755%
RH respectively. The samples are tested for every 1-month up to 6 months and the tabulated
analytical results are presented in the following pages. The results found to be within the
specification and no definite trend is observed.
In the year 2005, accelerated stability testing is initiated for six Iron Sucrose (Liquid) batches
(B.No.: G001, G002 and G003) (2G001, 2G002 and 2G003).
Long Term Stability:
Long term stability studies are initiated with samples from six manufacturing batches. The
samples are packed in small HDPE Drums and kept in an environment chamber. The
temperature and relative humidity in the chamber are maintained at 252oC and 605% RH
respectively. The samples were tested every month up to 6 months and 3 months interval up
to 1 year and 6 months interval during the second year and one year interval the after.
In the year 2005, long term stability testing is initiated for six Iron Sucrose (Liquid) batches
(B.No.: G001, G002 and G003) (2G001, 2G002 and 2G003).
The samples are stable at long term conditions up to 36 months data station and degradation
is not observed in any of the samples, and definite trend too not observed in the test results.
Note: The Iron sucrose batches, G001, G002 and G003 at 36 months data station, tested for
bacterial endotoxins and Microbial content and found compliant with the requirement.
Re-Test Date:
Based on the available data from the accelerated stability studies carried out for 6 months and
from the long term stability data up to 36 months, a re-test date of three years has been
assigned.
Note: The material of the containers used for the stability is the same that of the container
used for routine storage.
Note: At the time of 24 months data station the Bacterial endotoxins and Microbial test
procedure was not specified in test procedure. However, the samples was analyzed at the 24
months data station. The results are given are as follows.
S.No
01.

02.

Test
Bacterial
Endotoxins
Microbial
Content

Specification
Not more than 1.26 Endotoxin units per mg
of Iron
a) Total bacterial count: NMT 100 cfu/g
b) Yeasts and moulds: NMT 10 cfu/g
c) Absence of Enterobacteriaceae: Should be
Absent
d) Absence of Pathogens: Absence of
Staphylococcus
aureus,
Pseudomonous
aeruginosa, Escherichia coli, Salmonella sp.

G001

Result
G002

G003

Complies

Complies

Complies

Absent
Absent
Absent

Absent
Absent
Absent

Absent
Absent
Absent

Absent

Absent

Absent

Since, the specification was not updated as on 10/03/2007 (24 months data station), this data
is not reflected in the stability data sheets of G001, G002 and G003.

S.7.2 Post Approval Stability Protocol

Stability program is introduced utilizing stimulated market containers kept at a temperature
252oC and relative humidity 605%. Long term stability testing is initiated on first six
validation batches first and thereafter a new batch shall be added for every 1 year.
Reprocessed batches (if any) shall be added to the stability program. The batch samples are
analyzed initially and then at 7 intervals of 3, 6, 9, 12, 18, 24 and 36 months. From each
batch 10 samples (quantity shall be adequate for two trials of specified tests) of Iron Sucrose
(Liquid) are taken and packed in sample bottles.
In the year 2006, B.No: 2IRS0010506 was added to the Long term stability program.
In the year 2007, B.No: 2 IRS0020807 was added to the Long term stability program.
The samples are analyzed for the specified stability tests Description, Assay for Iron,
molecular weight, Specific gravity, alkalinity, pH, osmolarity, Turbidity, Low molecular
weight Fe(II) and Fe(III) complexes, Limit of Iron(II), Content of Chloride, Assay for sucrose
in both accelerated studies and long term stability studies.
New additional tests
Limit of 5-(Hydroxy methyl) Furfural
Bacterial Endotoxins and
Microbial content
Effective from May14th in the year 2007 are included in Stability program monitoring.
New additional test
Limit of Furfural
Effective from Sep. 24th in the year 2007 are included in stability program monitoring.
New additional test
Limit of glucose & Fructose (by HPLC)
Effective from Oct. 3nd in the year 2007 are included in Stability program monitoring.