Product Overview
High -purity Lactose Monohydrate tsim nyob rau hauv nruj GMP ua raws. Nws ua haujlwm ua cov khoom noj muaj txiaj ntsig zoo, khi, thiab muab tub lim rau cov tshuaj ntsiav tshuaj, tshuaj ntsiav filling, thiab cov khoom noj me nyuam mos. Engineered rau txhim khu kev qha compaction zog thiab exceptional batch - mus rau -batch sib xws.
Technical Specifications & Pharmacopeial Ua Raws Cai
Txhua qhov khoom xa tuaj yog nrog los ntawm ib pawg- Daim Ntawv Pov Thawj Tshwj Xeeb ntawm Kev Ntsuam Xyuas (COA) ua raws li USP, EP, BP, thiab ChP cov qauv:
|
Cov khoom |
Specifications |
Tus nqi |
|
Qhov tshwm sim |
Dawb crystalline granule los yog hmoov, tsw ntxhiab, qab qab zib. |
Ua tau raws li qhov yuav tsum tau ua. |
|
Solubility |
Soluble hauv dej, tab sis insoluble hauv ethanol, chloroform thiab ethyl ether. |
Ua tau raws li qhov yuav tsum tau ua. |
|
Specific Optical Rotation |
+52.3℃-+52.6 degree |
+52.3 degree |
|
Dej / Crystalline Moisture (Karl Fischer, %) |
4.5-5.5 |
5.0 |
|
Cov ntsiab lus (%) |
98.0-102.0 |
99.7 |
|
Residue ntawm Ignition (%) |
Tsawg dua los yog sib npaug rau 1.0 |
0.03 |
|
Poob rau ziab / Dawb Moisture (%) |
Tsawg dua los yog sib npaug rau 1.0 |
0.11 |
|
Elemental Impurities (Ua raws li ICH Q3D) |
Tsawg dua lossis sib npaug li 5ppm |
Ua tau raws li qhov yuav tsum tau ua |
|
Arsenic (As) |
Tsawg dua lossis sib npaug li 2 ppm |
Ua tau raws li qhov yuav tsum tau ua |
|
pH |
4.0-7.0 |
4.8 |
|
Total Aerobic Microbial Count (TAMC) |
Tsawg dua lossis sib npaug li 1000 cfu / g |
< 10 cfu/g |
|
Total Combined Poov thiab Pwm suav (TYMC) |
Tsawg dua lossis sib npaug li 100 cfu / g |
< 10 cfu/g |
|
Escherichia coli |
Nrhiav tsis tau |
Ua tau raws li qhov yuav tsum tau ua |
Core Advantages & Technical Evidence
High Purity (99.7% Kev Ntsuas)
Qhov tseeb:Ua tau raws li -tier pharmacopeial qauv.
Kev tshawb fawb:Multi-theem crystallization tshem tawm txo cov suab thaj, tiv thaiv Maillard (browning) cov tshuaj tiv thaiv nrog amine APIs.
Tsawg Moisture & High Flowability
Qhov tseeb:Dawb ya raws (LOD) Tsawg dua lossis sib npaug li 0.11%; ruaj khov crystal noo ntawm 5.0%.
Qhov tshwm sim:Fluidized- txaj kom qhuav tshem tawm cov dej saum npoo av, tiv thaiv kev thauj mus los thiab ua kom du, siab - ntsiav tshuaj ceev.
Kev tswj hwm nruj Microbe
Qhov tseeb:Ultra-low bioburden (TAMC/TYMC < 10 cfu/g); E. coli tsis paub.
Infrastructure:Automated, kaw- voj ISO 8 (Class 100,000) cov chav huv huv tshem tawm cov kab sib kis -.
Daim Ntawv Thov & Qib Kev Qhia Qhia
Lactose particle loj thiab lub cev daim ntawv nruj me ntsis hais nws qhov kev ua tau zoo hauv cov khoom noj khoom haus thiab khoom noj khoom haus. Tshawb xyuas peb cov lus qhia xaiv hauv qab no kom phim koj cov txheej txheem tshwj xeeb:
|
Mesh / Qib Loj |
Core Applications |
Optimized Manufacturing txheej txheem |
|
100 Mesh / 200 Mesh (Fine Crystalline Hmoov) |
• Cov ntsiav tshuaj txheem • Hard gel capsule filling • Khoom noj khoom haus hmoov sib tov |
ntub Granulation & Encapsulation Muab kev khi zoo heev thiab sib xyaw ua ke nrog APIs. |
|
Direct Compression (DC) Lactose Excipient (Txaus-Kub / Agglomerated) |
• Siab- ceev ceev cov ntsiav tshuaj • Moisture -sensitive formulations |
Direct Compression (DC) Engineered rau tshwj xeeb hmoov flowability thiab pom cov ntsiav tshuaj hardness yam tsis muaj granulation. |
|
Cov Me Nyuam Me Me Qib Qib |
• Khoom noj khoom haus zoo rau menyuam mos • Khoom noj khoom haus- raws li kev ua haujlwm |
Kev sib xyaw ntub / qhuav (Food Standard) Kev soj ntsuam nruj me ntsis rau nitrate, nitrite, thiab ultra-tsawg microbiological txwv nyob rau hauv tag nrho ua raws li thoob ntiaj teb cov me nyuam mos noj zaub mov kev ruaj ntseg cov cai (piv txwv li, EU, FDA). |
Customization Muaj:Xav tau ib qho tshwj xeeb particle loj faib (PSD) rau ib qho nyuaj formulation? Peb muab customized milling thiab sifting (los ntawm 60 mesh mus rau 325 mesh). Hu rau peb pab neeg technical rau kev cai specs.
Regulatory Qualifications & Certifications
Txhawm rau kom muaj kev pom zoo kev tswj hwm seamless rau koj cov qauv, peb cov chaw tsim khoom thiab cov khoom lag luam tuav cov ntawv pov thawj thoob ntiaj teb hauv qab no:
GMP Certified Facility -Kev tshuaj xyuas tag nrho cov kab ntau lawm rau cov kws tshuaj -qib excipients.
Regulatory Documentation Supplied –DMF (Drug Master File) sau npe, CEP/COS muaj raws li qhov kev thov.
Ntiaj teb no Food Safety Standards –ISO 9001, ISO 22000, FSSC 22000 tau ntawv pov thawj.
Kev ua raws li kev noj haus -Kosher thiab Halal tau ntawv pov thawj.
Cov nqe lus muaj -TSE/BSE- Daim Ntawv Qhia Dawb, Daim Ntawv Qhia Allergen, thiab Tsis yog -GMO Tshaj Tawm.
FAQ
Cim npe nrov: Tuam Tshoj lactose monohydrate anhydrous manufacturers, lwm tus neeg