Analysis Service

In addition to contract manufacturing,
we also conduct various quality tests
essential for pharmaceutical quality
control.

Service Overview

We offer various quality testing services based on the Japanese GMP Regulations (Good Manufacturing Practice).
These tests include compliance with official compendiums such as the Japanese Pharmacopoeia (JP), The Japanese standards for non-Pharmacopoeia crude drugs, Japanese Pharmaceutical Excipients, and Japanese Standards of Quasi-Drugs Ingredients.
We conduct a variety of tests, including stability testing (long-term, accelerated^*1, and harsh condition tests^*2), to ensure compliance with individual client approval standards.

We also support antibiotic potency testing using the cylinder-plate method.

^{*1 , *2} We outsource storage, while the testing procedures are performed by our company.

To efficiently control and track all sample handling, test data, and final analytical results, our company utilizes a Laboratory Information Management System (LIMS)

Available Tests

Raw material testing (active pharmaceutical ingredient, excipients)
Testing of packaging materials
Formulation testing (injections, tablets, etc.)
Stability testing (long-term storage testing, accelerated testing^*1 )
Analytical method validation
Microbiological testing (sterility, microbial limit, cylinder-plate method etc.)
Endotoxin testing
Pharmaceutical water (ordinary water^*2 , purified water)
Foreign matter inspection (measurement using membrane filter, electron microscopy and FT-IR spectroscopy)

^*1 We outsource storage, while the testing procedures are performed by our company.
^*2 Partially

Analysis Equipment

Equipment	Number	Equipment	Number
Gas chromatograph	2	Electrical conductivity meter	1
Liquid chromatograph	23	Karl fischer moisture meter	7
Powder X-ray diffraction instrument	1	pH meter	2
Atomic absorption spectrophotometer	1	Melting point apparatus	1
UV-Vis spectrophotometer	4	Semi-micro Kjeldahl apparatus	1
FT-IR／FT-NIR	4	Total organic carbon analyzer	1
Raman spectrophotometer	2	Ultrapure water system	1
Polarimeter	1	Microscope	1
Turbidity meter	1	Polarized light microscope	1
Refractometer	1	Electric burette	1
Osmometer	1	Electronic balance	20
Dissolution apparatus	6	Electric furnace	3
Disintegration tester	1	Automatic titrator	1
Wellreader	1	Isolator	1
Viscometer	3	Incubator	13
Insoluble particle counter	1	Autoclave	2