Products
Ursodeoxycholic Acid (UDCA) yeDeebio Yekurapa Gallstones
Detail
1. Hunhu: Hupfu chena;isina hwema.Ichi chigadzirwa chinonyungudika mu ethanol, asi chisinganyunguriki mu chloroform;soluble mu glacial acetic acid, uye soluble mu sodium hydroxide test solution.
2. Maitiro: Synthetic.
3. Zvinoratidza uye kushandiswa: Pakurapa gallstones, cholestatic chiropa chirwere, mafuta chiropa, akasiyana marudzi hepatitis, chepfu chiropa kusagadzikana, cholecystitis, cholecystitis uye biliary dyspepsia, bile reflux gastritis, nezvimwewo.
Sei isu?
· Yakagadzirwa mumusangano weGMP
· Makore makumi maviri nemanomwe ebhayoloji enzyme R&D nhoroondo
·Maraw materials anotarisika
· Tevedzera mutengi uye bhizinesi mwero
·Tumira kunze kwenyika dzinopfuura makumi matatu nematunhu
·Ane kugona kwemhando yekutonga system seUS FDA, Japan PMDA, South Korea MFDS, nezvimwe.
Tsanangudzo
| Test Items | Zvinoenderana nemukati mwero uye Mutengi Standard | |
| KUONEKWA | Muchena kana hupfu hunenge huchena. | |
| MELTING RANGE | Pakati pe200°C ne205°C | |
| CHAIKO KUTENANA | +57.0 〜+62.0° | |
| KURASIKA PAKUOMESA | ≤0.5% | |
| RASIDUE PAIGNITION | ≤0.1% | |
| ASSAY | 98.5%〜101.5% (Dried substance) | |
| KUCHENA (HPLC) | ≥98.5% | |
| RELATED SUBSTANCE (HPLC) | ≤1.5% (Chenodeoxycholicacid) | Haisati yaonekwa |
| ≤0.1% (kusvibiswa kusingazivikanwe) | 0.05% | |
| ≤0.1% (Lithocholicacid) | Haisati yaonekwa | |
| ≤1.5% (Zvose) | 0.10% | |
| RELATED SUBSTANCE (TLC) | ≤O.05% (Lithocholic acid) | Zvinoenderana |
| ≤1.5% (Chenodeoxycholicacid) | Zvinoenderana | |
| RASIDUAL SOLVENT | Acetone: ≤5000ppm | |
| TOTAL AEROBIC MICROBIAL COUNT | ＜103cfu/g | |
| ZVINHU ZVOSE ZVAKAsanganiswa YEAST/MOULDS COUNT | ＜102cfu/g | |
| E.COLI | Zvinoenderana | |
| SALMONELLAE | Zvinoenderana | |
| MHEDZISO | Qualified | |
