Pregnancy Plus Iodine Tablet, Catalent Australia Pty Ltd, CON-288
Product name
Pregnancy Plus Iodine Tablet
Sponsor name
Catalent Australia Pty Ltd
ARTG
Consent start
Consent no.
CON-288
Standard
Subsections 11(a), 11(b) and 11(c) of the Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO78).
Non-compliance with standard
Subsection 11(a) requires that a registered tablet or capsule without an
individual British Pharmacopoeia (BP) monograph must comply with the test for
Uniformity of Dosage Units of the BP, in the general monographs 'Tablets' or
'Capsules', respectively. With respect to a registered tablet or capsule without
an individual BP monograph, subsection 11(b) requires that the average content
of each active ingredient in a pooled sample of not fewer than 20 tablets or
capsules must be not less than 92.5% and not more than 107.5 % of the stated
content of that active ingredient. With respect to subsection 11(c), TGO 78
requires that a registered tablet or capsule without an individual BP monograph
must comply with a suitable test for dissolution that demonstrates the
appropriate release of each active ingredient for which the BP or United States
Pharmacopeia-National Formulary (USP-NF) includes an individual monograph for a
tablet or capsule and requires a test for dissolution.
Conditions imposed
1. The goods are not required to comply with TGO 78 subsection 11(a) but
must comply with the requirements of the British Pharmacopoeia Appendix XII C
Uniformity of Weight (Mass).
2. The goods are not required to comply with TGO 78 subsection 11(b) but the
average content of each active ingredient in the goods must comply with the
relevant acceptance criteria in the below tables#58;
FINISHED PRODUCT SPECIFICATIONS TO WHICH THE GOODS MUST CONFORM
Test
Acceptance criteria
Appearance
White film coated, oval shaped tablets.
Uniformity of mass
Meets the requirements of Uniformity of Weight (Mass), Appendix XII C
of the British Pharmacopoeia.
Average mass
1277mg ±5% (1214-1340mg)
Disintegration time
Meets the requirements for disintegration for film coated tablets of
the British Pharmacopoeia, Formulated preparations#58; General monographs for
Tablets.
Dissolution - folic acid
Meets the requirements of United States Pharmacopeia-National
Formulary, Dietary Supplement Chapter lt;2040gt; 'Disintegration and Dissolution
of Dietary Supplements'.
Dissolution - riboflavin (Vitamin B2)
Meets the requirements of United States Pharmacopeia-National
Formulary, Dietary Supplement Chapter lt;2040gt; 'Disintegration and Dissolution
of Dietary Supplements'.
Dissolution - iron
Meets the requirements of United States Pharmacopeia-National
Formulary, Dietary Supplement Chapter lt;2040gt; 'Disintegration and Dissolution
of Dietary Supplements'.
Identification
Thiamine (Vitamin B1)
Complies
Riboflavin (Vitamin B2)
Complies
Nicotinamide
Complies
Pantothenic acid (Vitamin B5)
Complies
Pyridoxine (Vitamin B6)
Complies
Cyanocobalamin (Vitamin B12)
Complies
Ascorbic Acid (Vitamin C)
Complies
Colecalciferol (Vitamin D3)
Complies
dl-alpha tocopherol (Vitamin E)
Complies
Biotin (Vitamin H)
Complies
Folic acid
Complies
Calcium
Complies
Copper
Complies
Iodine
Complies
Iron
Complies
Magnesium
Complies
Manganese
Complies
Selenium
Complies
Zinc
Complies
Acceptance criteria for Assay of Active ingredients
Test (Assay)
Acceptance limits (release)
Acceptance limits (shelf life)
Vitamin B5 (pantothenic acid as calcium pantothenate)
115.6% '“ 150.0%
of labelled claim
90.0% '“ 150.0%
of labelled claim
Nicotinamide
115.6% '“ 150.0%
of labelled claim
90.0% '“ 150.0%
of labelled claim
Pyridoxine (Vitamin B6, as pyridoxine hydrochloride)
115.6% '“ 150.0%
of labelled claim
90.0% '“ 150.0%
of labelled claim
Vitamin B2 (riboflavin)
115.6% '“ 150.0%
of labelled claim
90.0% '“ 150.0%
of labelled claim
Thiamine (Vitamin B1, as thiamine nitrate)
115.6% '“ 150.0%
of labelled claim
90.0% '“ 150.0%
of labelled claim
Vitamin C (ascorbic acid)
115.6 '“ 150.0%
of labelled claim
90.0% '“ 150.0%
of labelled claim
dl-alpha tocopherol (Vitamin E, as dl-alpha-tocopheryl acetate)
100.8% '“ 130.8%
of labelled claim
90.0% '“ 165.0%
of labelled claim
Colecalciferol (as dry Vitamin D3 200IU)
129.5% '“ 149.8%
of labelled claim
90.0% '“ 165.0%
of labelled claim
Folic acid
115.6% '“ 150.0%
of labelled claim
90.0% '“ 150.0%
of labelled claim
Iron (as ferrous fumarate)
92.5% '“ 125.0%
of labelled claim
90.0% '“ 125.0%
of labelled claim
Magnesium (as magnesium oxide-heavy and magnesium stearate)
92.5% '“ 125.0%
of labelled claim
90.0% '“ 125.0%
of labelled claim
Calcium (as calcium hydrogen phosphate, calcium carbonate and
calcium pantothenate)
92.5% '“ 125.0%
of labelled claim
90.0% '“ 125.0%
of labelled claim
Zinc (as zinc citrate dihydrate)
92.5% '“ 125.0%
of labelled claim
90.0% '“ 125.0%
of labelled claim
Copper (as cupric sulfate)
92.5% '“ 125.0%
of labelled claim
90.0% '“ 125.0%
of labelled claim
Manganese (as manganese sulfate monohydrate)
92.5% '“ 125.0%
of labelled claim
90.0% '“ 125.0%
of labelled claim
Iodine (as potassium iodide)
92.5% '“ 160.0%
of labelled claim
90.0% '“ 160.0%
of labelled claim
Selenium (as sodium selenite)
92.5% '“ 160.0%
of labelled claim
90.0% '“ 160.0%
of labelled claim
Biotin
Label Claim#58; 30.0 mcg (QBI)
Label Claim#58; 30.0 mcg (QBI)
Vitamin B12 (cyanocobalamin )
Label Claim#58; 2.60 mcg (QBI)
Label Claim#58; 2.60 mcg (QBI)
Microbial requirements
Test
Requirement
Total aerobic microbial count
‰¤ 104 microorganisms/g
Total yeast and mould count
‰¤ 102 microorganisms/g
Bile-tolerant Gram negative bacteria
‰¤ 102 microorganisms/g
Salmonella
Absent in 10g
Escherichia coli
Absent in 1g
Staphylococcus aureus
Absent in 1g
Note#58; Microbial testing shall be performed on first 3 production batches
and at least one batch per year or when a change in the source of raw materials
or manufacturing environment process occurs.
3. The goods are not required to comply with TGO 78 subsection 11(c) but
must comply with the dissolution requirements of the United States
Pharmacopeia-National Formulary, Dietary Supplement Chapter lt;2040gt;
'˜Disintegration and Dissolution of Dietary Supplements'™ for riboflavin (Vitamin
B2) and iron as set out in the above tables.
Therapeutic product type
Registered complementary medicines