Detecting and quantifying specific microorganisms that may be present in pharmaceutical
products, including bacteria, fungi, and pathogens.
๐๐ฎ๐บ๐ฝ๐น๐ฒ ๐: Take 10 g of sample and add to SCDM 90 ml 1:10 (TAMC and TYMC).
๐๐ฎ๐บ๐ฝ๐น๐ฒ ๐: Take 10 ml from sample A and add it to 90 ml SCDM at a 1:100 ratio (pathogen
test).
๐๐ฎ๐บ๐ฝ๐น๐ฒ ๐: Add 90 ml of SCDM to a 10g/ml sample (for the salmonella test).
Discard Sample A
Samples B and C incubate at 30-35ยฐC for 24 hours.
๐๐๐ญ๐ก๐จ๐ ๐๐ง ๐๐๐ฌ๐ญ
๐.๐๐จ๐ฅ๐ข ๐ญ๐๐ฌ๐ญ
Add 1ml of sample B to the MCB and incubate at 42-44 ยฐC for 48 hours. Then, streak on an
MCA plate and incubate for 72 hours.
Color indication: brick red
๐๐๐ฅ๐ฆ๐จ๐ง๐๐ฅ๐ฅ๐ ๐ญ๐๐ฌ๐ญ
Add 0.1ml of sample C to the 10mL RVSEB and incubate at 30-35ยฐC for 48hrs. Then, streak
on an XLDA plate and incubate for 48 hours at 30-35ยฐC.
Indication with or without black center.
๐๐ฌ๐๐ฎ๐๐จ๐ฆ๐จ๐ง๐๐ฌ ๐ญ๐๐ฌ๐ญ
Incubate the sample B streak on a CA plate at 30-35 degrees Celsius for 72 hours.
Indication: fluorescent green color.
๐๐ญ๐๐ฉ๐ก๐ฒ๐ฅ๐จ๐๐จ๐๐๐ฎ๐ฌ ๐ญ๐๐ฌ๐ญ
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>
