(주)바이오스트림 시험분석센터

MFDS-Designated Dosage Forms and Test Items

Category	Form	Test Method
Mandatory Designation	Common	Appearance Test
		Loss on Ignition Test
		Residue on Ignition Test
		Loss on Drying Test
		pH
Mandatory Designation By Dosage Form	Common	Metallic Foreign Matter Test
		(Insoluble) Particulate Matter Test
		Mass And Volume Test
		Extractable Volume Test For Injections
Pharmacopoeial Test	Injectable Product	Particulate Matter Test For Injections Method 1
		Particulate Matter Test For Injections Method 2
		Sterility Test_Membrane Filtration Method Suitability Test (Package Integrity + Sample)
		Sterility Test_Membrane Filtration Method Suitability Test (Sample)
		Sterility Test_Membrane Filtration Method
		Sterility Test_Direct Inoculation Method Suitability Test (Package Integrity + Sample)
		Sterility Test_Direct Inoculation Method Suitability Test (Sample)
		Sterility Testing_Direct Inoculation Method
		Bacterial Endotoxins Test_Turbidimetric Method Suitability Test
		Bacterial Endotoxins Test_Turbidimetric Method
		Bacterial Endotoxins Test_Chromogenic Method Suitability Test
		Bacterial Endotoxins Test_Chromogenic Method
	Ophthalmic Solution	Microbiological Potency Test For Antibiotics Cylinder Plate Method
	Ophthalmic Solution	Test for Insoluble Particulate Matter in Ophthalmic Preparations
	Liquid Preparations	Microbial Limit Test_Method Suitability Test for Microbial Enumeration by Membrane Filtration
		Microbial Limit Test_Microbial Enumeration by Membrane Filtration
		Microbial Limit Test_Method Suitability Test for Microbial Enumeration by Pour-Plate Method
		Microbial Limit Test_Microbial Enumeration by Pour-Plate Method
		Microbial Limit Test_Method Suitability Test for Microbial Enumeration by Spread-Plate Method
		Microbial Limit Test_Microbial Enumeration by Spread-Plate Method
	Semi Solid Preparations	Microbial Limit Test: Escherichia coli Test Method Suitability Test
		Microbial Limit Test: Escherichia coli Test
		Microbial Limit Test: Salmonella Test_Method Suitability Test
		Microbial Limit Test: Salmonella Test
		Microbial Limit Test: Pseudomonas aeruginosa Test_Method Suitability Test
		Microbial Limit Test: Pseudomonas aeruginosa Test
		Microbial Limit Test: Staphylococcus aureus Test_Method Suitability Test
		Microbial Limit Test: Staphylococcus aureus Test
		Microbial Limit Test: Clostridia Test_Method Suitability Test
		Microbial Limit Test: Clostridia Test
		Microbial Limit Test: Candida albicans Test_Method Suitability Test
		Microbial Limit Test: Candida albicans Test
		Microbial Limit Test: Bile-Tolerant Gram-Negative Bacteria (Qualitative) Test_Method Suitability Test
		Microbial Limit Test: Bile-Tolerant Gram-Negative Bacteria (Qualitative) Test
		Microbial Limit Test: Bile-Tolerant Gram-Negative Bacteria (Quantitative) Test_Method Suitability Test
		Microbial Limit Test: Bile-Tolerant Gram-Negative Bacteria (Quantitative) Test