but i thought overage based on degradation was only allowed with Vitamins products. Does it also apply for antibiotic products such as cefixime in Dry syrup form? Can anyone point out some regulatory guidance which clarifies overage incorporation? Cefixime has assay range 90-120 %.
but i thought overage based on degradation was only allowed with Vitamins products. Does it also apply for antibiotic products such as cefixime in Dry syrup form? Can anyone point out some regulatory guidance which clarifies overage incorporation? Cefixime has assay range 90-120 %.
In general, use of an overage of a drug substance to compensate for degradation during manufacture or a product’s shelf life, or to extend shelf life, is discouraged. Any overages in the manufacture of the drug product, whether they appear in the final formulated product or not, should be justified considering the safety and efficacy of the product. Information should be provided on the 1) amount of overage, 2) reason for the overage (e.g., to compensate for expected and documented manufacturing losses), and 3) justification for the amount of overage. The overage should be included in the amount of drug substance listed in the batch formula.
In general, use of an overage of a drug substance to compensate for degradation during manufacture or a product’s shelf life, or to extend shelf life, is discouraged. Any overages in the manufacture of the drug product, whether they appear in the final formulated product or not, should be justified considering the safety and efficacy of the product. Information should be provided on the 1) amount of overage, 2) reason for the overage (e.g., to compensate for expected and documented manufacturing losses), and 3) justification for the amount of overage. The overage should be included in the amount of drug substance listed in the batch formula.
Waiting for Cefixime oral suspension usp justification. Why usp limit is 90-120% Can we add 110% cefixime, if usp limit is broader?? Why usp limit is broader ??
Waiting for Cefixime oral suspension usp justification. Why usp limit is 90-120% Can we add 110% cefixime, if usp limit is broader?? Why usp limit is broader ??
According to the Indian Drugs & Cosmetics Act 1940 & Rules thereunder 1945 overages of vitamins, Enzymes and antibiotics are acceptable. Please note the following requirement under Schedule V of this act & Rules. "STANDARDS FOR PATENT OR PROPRIETARY MEDICINES: The content of active ingredients, other than vitamins, enzymes and antibiotics, in patent or proprietary medicines shall be not less than 90 per cent and not more than 110 per cent of the labelled content; however, for enzymes and vitamins, only for lower limit of 90 per cent shall apply. In all dry formulations containing antibiotics, the limit shall be 90 to 130 per cent of the labelled contents and in case of liquid antibiotic formulations, the limit shall be 90 to 140 per cent of labelled contents." This clearly indicates that there is no higher limit of assay content of vitamins and enzymes with respect to the labelled amount. It all depends upon the stability of the vitamins and enzymes formulations stability profile until specified shelf life.
According to the Indian Drugs & Cosmetics Act 1940 & Rules thereunder 1945 overages of vitamins, Enzymes and antibiotics are acceptable. Please note the following requirement under Schedule V of this act & Rules. "STANDARDS FOR PATENT OR PROPRIETARY MEDICINES: The content of active ingredients, other than vitamins, enzymes and antibiotics, in patent or proprietary medicines shall be not less than 90 per cent and not more than 110 per cent of the labelled content; however, for enzymes and vitamins, only for lower limit of 90 per cent shall apply. In all dry formulations containing antibiotics, the limit shall be 90 to 130 per cent of the labelled contents and in case of liquid antibiotic formulations, the limit shall be 90 to 140 per cent of labelled contents." This clearly indicates that there is no higher limit of assay content of vitamins and enzymes with respect to the labelled amount. It all depends upon the stability of the vitamins and enzymes formulations stability profile until specified shelf life.
According to USP the assay limit for Oral Suspension (Dry syrup) is 90- 120 %. In our formulation we had 10 % Overages. How can we justify the overages since there is no variability in manufacturing and testing method (system suitability RSD less than 2%). Can we put overages based on assay limit which is higher than usual limit (90-110 %) ?
According to USP the assay limit for Oral Suspension (Dry syrup) is 90- 120 %. In our formulation we had 10 % Overages. How can we justify the overages since there is no variability in manufacturing and testing method (system suitability RSD less than 2%). Can we put overages based on assay limit which is higher than usual limit (90-110 %) ?
Sabyata Pharmacy: overage would be justified by assay content degradation over time (syrup, liquid formulation), not by manufacture and testing.
Sabyata Pharmacy: overage would be justified by assay content degradation over time (syrup, liquid formulation), not by manufacture and testing.
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but i thought overage based on degradation was only allowed with Vitamins products. Does it also apply for antibiotic products such as cefixime in Dry syrup form? Can anyone point out some regulatory guidance which clarifies overage incorporation? Cefixime has assay range 90-120 %.
but i thought overage based on degradation was only allowed with Vitamins products. Does it also apply for antibiotic products such as cefixime in Dry syrup form? Can anyone point out some regulatory guidance which clarifies overage incorporation? Cefixime has assay range 90-120 %.
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How to Justify Higher Overages of more than 50% in Vitamines like Colecalciferol or Pyridoxine?
How to Justify Higher Overages of more than 50% in Vitamines like Colecalciferol or Pyridoxine?
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In general, use of an overage of a drug substance to compensate for degradation during manufacture or a product’s shelf life, or to extend shelf life, is discouraged. Any overages in the manufacture of the drug product, whether they appear in the final formulated product or not, should be justified considering the safety and efficacy of the product. Information should be provided on the
1) amount of overage,
2) reason for the overage (e.g., to compensate for expected and documented manufacturing losses), and
3) justification for the amount of overage.
The overage should be included in the amount of drug substance listed in the batch formula.
In general, use of an overage of a drug substance to compensate for degradation during manufacture or a product’s shelf life, or to extend shelf life, is discouraged. Any overages in the manufacture of the drug product, whether they appear in the final formulated product or not, should be justified considering the safety and efficacy of the product. Information should be provided on the
1) amount of overage,
2) reason for the overage (e.g., to compensate for expected and documented manufacturing losses), and
3) justification for the amount of overage.
The overage should be included in the amount of drug substance listed in the batch formula.
More
VOTE
Waiting for Cefixime oral suspension usp justification.
Why usp limit is 90-120%
Can we add 110% cefixime, if usp limit is broader??
Why usp limit is broader ??
Waiting for Cefixime oral suspension usp justification.
Why usp limit is 90-120%
Can we add 110% cefixime, if usp limit is broader??
Why usp limit is broader ??
More
VOTE
According to the Indian Drugs & Cosmetics Act 1940 & Rules thereunder 1945 overages of vitamins, Enzymes and antibiotics are acceptable.
Please note the following requirement under Schedule V of this act & Rules.
"STANDARDS FOR PATENT OR PROPRIETARY MEDICINES:
The content of active ingredients, other than vitamins, enzymes and antibiotics, in patent or proprietary medicines shall be not less than 90 per cent and not more than 110 per cent of the labelled content; however, for enzymes and vitamins, only for lower limit of 90 per cent shall apply. In all dry formulations containing antibiotics, the limit shall be 90 to 130 per cent of the labelled contents and in case of liquid antibiotic formulations, the limit shall be 90 to 140 per cent of labelled contents."
This clearly indicates that there is no higher limit of assay content of vitamins and enzymes with respect to the labelled amount. It all depends upon the stability of the vitamins and enzymes formulations stability profile until specified shelf life.
According to the Indian Drugs & Cosmetics Act 1940 & Rules thereunder 1945 overages of vitamins, Enzymes and antibiotics are acceptable.
Please note the following requirement under Schedule V of this act & Rules.
"STANDARDS FOR PATENT OR PROPRIETARY MEDICINES:
The content of active ingredients, other than vitamins, enzymes and antibiotics, in patent or proprietary medicines shall be not less than 90 per cent and not more than 110 per cent of the labelled content; however, for enzymes and vitamins, only for lower limit of 90 per cent shall apply. In all dry formulations containing antibiotics, the limit shall be 90 to 130 per cent of the labelled contents and in case of liquid antibiotic formulations, the limit shall be 90 to 140 per cent of labelled contents."
This clearly indicates that there is no higher limit of assay content of vitamins and enzymes with respect to the labelled amount. It all depends upon the stability of the vitamins and enzymes formulations stability profile until specified shelf life.
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VOTE
I have an example of Colecalciferol from Essential UK, being sold with 50% overages.
Mecobalamine in India is being sold with 100% overages!
I have an example of Colecalciferol from Essential UK, being sold with 50% overages.
Mecobalamine in India is being sold with 100% overages!
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Can we mention the overages by specifying it as stability overages or manufacturing overages for API, not salts?
Can we mention the overages by specifying it as stability overages or manufacturing overages for API, not salts?
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According to USP the assay limit for Oral Suspension (Dry syrup) is 90- 120 %. In our formulation we had 10 % Overages. How can we justify the overages since there is no variability in manufacturing and testing method (system suitability RSD less than 2%).
Can we put overages based on assay limit which is higher than usual limit (90-110 %) ?
According to USP the assay limit for Oral Suspension (Dry syrup) is 90- 120 %. In our formulation we had 10 % Overages. How can we justify the overages since there is no variability in manufacturing and testing method (system suitability RSD less than 2%).
Can we put overages based on assay limit which is higher than usual limit (90-110 %) ?
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VOTE
So, If I have a good justification I can increase the overage of the finished product up to the upper pharmacopeial limits.
So, If I have a good justification I can increase the overage of the finished product up to the upper pharmacopeial limits.
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