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IPC introduces draft amendment to microbial contamination in non-sterile products in IP 2022
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Laxmi Yadav, Mumbai
October 31 , 2022
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In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022.
The new draft amendment released by IPC on October 26, 2022 introduced changes to enumeration of aerobic microorganisms present in the product as well as modification in microbial contamination in barium sulphate oral suspension, microcrystalline cellulose and starch.
The draft amendment increased the number of colonies for total fungal count to 50 from 25 in the pour-plate method used for enumeration of aerobic microorganisms present in the product. It says, “Then select the plates corresponding to a given dilution and showing the highest number of colonies but less than 250 for aerobic microorganisms and 50 colonies for total fungal count.” Earlier it was 25 colonies for total fungal count.
The draft says barium sulphate oral suspension should be free from contamination of Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa, Salmonella species.
Earlier IP stated that the total aerobic viable count is not more than 100 cfu per ml, the total combined molds and yeasts count is not more than 10 cfu per ml. 1 g is free from Staphylococcus aureus and Pseudomonas aeruginosa and 10 g is free from Salmonella species.
The new draft amendment says, “The total aerobic viable count is not more than 100 cfu per ml, the total combined molds and yeasts count is not more than 10 cfu per ml. 1 g is free from Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa and 10 g is free from Salmonella species.”
The draft added microbial contamination to microcrystalline cellulose after loss on drying. As per the newly added microbial contamination, “The total aerobic viable count is not more than 1000 cfu per g and total fungal count is not more than 100 cfu per g. 1 g is free from Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa and 10 g is free from Salmonella and Shigella.”
Similarly, the IPC introduced aerobic viable count and fungal count to microbial contamination of starch. The newly added draft amendment says “The total aerobic viable count is not more than 1000 cfu per g, the total fungal count is not more than 100 cfu per g, determined by plate count. 1 g is free from Escherichia coli and 10 g is free from Salmonella and Shigella.” Earlier aerobic viable count and fungal count were not mentioned in IP.
Furthermore, as the new draft amendment, bacterial endotoxin will be counted in phenylephrine hydrochloride rather than phenylephrine injection. It introduced changes from ‘not more than 25.0 endotoxin units per mg of phenylephrine’ to ‘not more than 25.0 endotoxin units per mg of phenylephrine hydrochloride’ in Phenylephrine Injection monograph in IP 2022. Bacterial endotoxins are a component of the cell wall of gram-negative bacteria.
In August 2022 IPC came up with a revised draft general chapter on microbiology in the IP which included revised bacterial endotoxin, revised effectiveness of antimicrobial preservatives, and revised microbial contamination in non-sterile products.
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