Detecting and quantifying specific microorganisms that may be present in pharmaceutical
products, including bacteria, fungi, and pathogens.
𝐒𝗮𝗺𝗽𝗹𝗲 𝗔: Take 10 g of sample and add to SCDM 90 ml 1:10 (TAMC and TYMC).
𝐒𝗮𝗺𝗽𝗹𝗲 𝐁: Take 10 ml from sample A and add it to 90 ml SCDM at a 1:100 ratio (pathogen
test).
𝐒𝗮𝗺𝗽𝗹𝗲 𝐂: Add 90 ml of SCDM to a 10g/ml sample (for the salmonella test).
Discard Sample A
Samples B and C incubate at 30-35°C for 24 hours.
𝐏𝐚𝐭𝐡𝐨𝐠𝐞𝐧 𝐓𝐞𝐬𝐭
𝐄.𝐜𝐨𝐥𝐢 𝐭𝐞𝐬𝐭
Add 1ml of sample B to the MCB and incubate at 42-44 °C for 48 hours. Then, streak on an
MCA plate and incubate for 72 hours.
Color indication: brick red
𝐒𝐚𝐥𝐦𝐨𝐧𝐞𝐥𝐥𝐚 𝐭𝐞𝐬𝐭
Add 0.1ml of sample C to the 10mL RVSEB and incubate at 30-35°C for 48hrs. Then, streak
on an XLDA plate and incubate for 48 hours at 30-35°C.
Indication with or without black center.
𝐏𝐬𝐞𝐮𝐝𝐨𝐦𝐨𝐧𝐚𝐬 𝐭𝐞𝐬𝐭
Incubate the sample B streak on a CA plate at 30-35 degrees Celsius for 72 hours.
Indication: fluorescent green color.
𝐒𝐭𝐚𝐩𝐡𝐲𝐥𝐨𝐜𝐨𝐜𝐜𝐮𝐬 𝐭𝐞𝐬𝐭
Incubate the sample B streak on an MSA plate at 30-35 degrees Celsius for 72 hours.
Indication golden yellow color colonies.
All the test according to specification.
Refer
USP <62>