Laboratory services (GLP)

I. BIMSIFRAM Analytical Laboratory

In 1996, with the cooperation of Sichuan University , we established the BIMSIFRAM Analytical Laboratory in Chengdu , China . The laboratory is in charge of products' Quality Control and the necessary experiments for COS and EDMF application. It also provides routine pharmacy examination, impurity analysis, detection of residual solvents, and the synthesis, separation and identification of chemical reference standards.

The area of the BIMSIFRAM Analytical Laboratory is about 100 square meters . There are several HPLCs, in which is a preparative chromatography, a GC, an auto polarimeter, and a UV spectrophotometer, etc.

Since many years, BIMSIFRAM Analytical Laboratory always operates according to the GLP regulations, insuring that the results are scientific and traceable.

Under the instruction of the experienced professors of pharmaceutics, using the advanced instruments in the Laboratory, and thanks to Sichuan University 's hardware and software, BIMSIFRAM Analytical Laboratory has contributed a lot to our 10 COS ' registration.

II. Services provided by BIMSIFRAM Analytical Laboratory

BIMSIFRAM Analytical Laboratory can provide 3 services: Drug Testing, Experiments for the application of COS/EDMF, and the preparation of chemical reference standards.

1. Drug Testing
The drug testing is according to the Pharmacopoeia standards and the clients' standards. Main content:
(1) Identification of drugs: by chemical methods, UV spectrophotometry, infrared spectrometry, and chromatography.
(2) Testing: chlorides, sulphates, iron salts, ammonia salts, heavy metals, and arsenic salts; residual organic solvents; related substances (by HPLC, TLC, and UV spectrophotometry , etc.).
(3) Assay testing of drugs: by volumetric, UV spectrophotometry, and GC.

2. Experiments for COS/EDMF: help the enterprises do the necessary experiments for the application of COS/EDMF.

3. Preparation of Chemical Reference Standards (synthesis, separation, etc.).

III. Main instruments in the Laboratory

Instruments	Usage	Specialty
A&D ER-182A Electronic Balance 0.1mg, 0.01mg	Sample weighing
Sartorius BP-211D Electronic Balance 0.1mg, 0.01mg	Sample weighing
Shimadzu LC-10AT vp Liquid chromatograph	Identification of drugs, determination of related substances and assay	Double-pump, Diode-array Detector(DAD), scan spectral peaks, peak purity check, and gradient elution
Shimadzu LC-10AT vp Liquid chromatograph	Identification of drugs, determination of related substances and assay
Shimadzu LC-6AD vp Liquid chromatograph	Preparation of Chemical Reference Standards, Conventional testing	Dual-use liquid chromatography instruments, for the preparation and analysis of chemical reference standards
Waters 600 Liquid chromatograph	Identification of drugs, determination of related substances and assay	With fluorescence detection, UV detector and automatic sampling system
A Shimadzu LC-6A vp Liquid chromatograph	Identification of drugs, determination of related substances and assay	Double-pump, gradient elution
GC122 Gas-Chromatograph	determination of residual solvents
WZZ-2A Automatic Polarimeter	Determination of specific rotation
Xintian FOIC WYA 811199 Refractometer	Determination of refractive index
UNICO UV- 2102C Spectrophotometer	Determination of absorbance and content
ZF-I UV analyzer	TLC detection	254nm, 365nm